Regulation and compliance
Medical-device regulation, compliance, submissions and post-market requirements.
Regulation and compliance
Format
NPPA Revises Coronary Stent Ceiling Prices in Line with WPI Growth
The revised coronary stent ceiling prices took effect in April 2024.
Understanding Europe's New Medical Device Regulation - MDR 2017/745
New MDR and IVDR regulations were approved in March 2017 by the European Council and in April 2017 by the European Parliament. Both regulations entered into force on May 26, 2017; new rules will apply starting May 26,…
Understanding Europe's New Medical Device Regulation - MDR 2017/745
What are the key changes of the regulation?
Medical Devices That Use Breathing Gas Pathways, Like Oxygen Masks, Can Pose Risks To Patients?
Air from the device and its parts can enter the patient's breathing passageways, exposing internal tissues to chemical emissions and condensates. Patients receiving supplemental oxygen can expose others to exhaled air…
Landmark Public-Private Partnership MoU Inked
AiMeD & Invest India sign a momentous MoU aimed at making India a global manufacturing hub for medical devices and components
Centre To Notify Revised Schedule M III For Medical Devices By June End
Following strong representation from the medical devices industry, the Centre has agreed to align Schedule MIII with IS/ISO 13485 by delinking it from Schedule M for Pharma. The revised Schedule MIII will be notified…
Separate Rules To Spur Medical Devices Sector Soon
In lines with the prime ministers ‘Make in India Campaign’, the department of industrial policy and promotion (DIPP) has identified medical devices as one among the top five sectors having good investment potential in…
China: Medical Technology Potentials Are Enormous
Health Industry Summit (CMEF) in Shanghai opens path to Chinese market, features products for global distribution.
100% FDI for Medical Devices Under ‘Automatic Route’ Now
The government has now allowed 100 per cent FDI under automatic route in medical devices sector to encourage manufacturing of equipments, including diagnostic kits and other devices. “Easing of norms for medical devic…
ASEAN Countries Could Be The Next Emerging MedTech Markets
Thanks to a large population, rising middle class, and increasing healthcare spending, the 10 countries that make up the Association of Southeast Asian Nations are gaining attention from medical device makers.
Experts Miffed Over Delay In NIPER Campus In Gandhinagar
Even after almost seven years since it received the Union Cabinet nod and land allotment by the state government, the National Institute of Pharmaceutical Education and Research (NIPER) campus at Gandhinagar in Gujara…
Key Country Assessments
Thailand : With a population of 67 million Thailand shares borders with Malaysia, Burma, Laos, and Cambodia. Per-capita healthcare spending in Thailand increased from $73 in 2002 to approximately $220 in 2013. The gov…
Pharmexcil to establish warehousing facility in Nigeria
The Pharmaceuticals Export Promotion Council of India (Pharmexcil), is planning to establish a warehousing facility in Nigeria to support Indian exporters in Africa.
D&C Rules On Labeling Norms, Shelf Life Of Medical Devices
The Centre is expected to further streamline the medical devices sector by suitably amending the norms on labeling, qualification for supervision of manufacturing of devices, quality standards and shelf life under the…
Design Clinic Scheme For Medical Devices Industry by NID (National Institute of Design)
Medical Devices being one of the important sectors with high potential for import substitute and exports, MSMEs in India have been able to achieve great success in creating breakthrough products.
Life Sciences And Medical Devices Sector In India: Highlights
(Sector Highlights By Frost And Sullivan Prepared For Panel Discussion On “Right Opportunities And Best Practices In BRIC Markets”)
China's Packaging Industry Luring Indian Companies
Indian Pharma Industry Keen On Innovative Packaging
Pharmexcil To Sign MoU With Japanese Industry Association Soon For Furthering Export Trade
The Pharmaceutical Export Promotion Council of India (Pharmexcil) is planning to sign a Memorandum of Understanding (MoU) with the Japanese pharma industry association with an aim to further improve India’s export tra…
Driving Biomedical Innovation : Initiatives To Improve Products For Patients
Because of its role as both a regulator and as a public health agency facilitating the development of new, innovative products to meet the needs of patients and the American public, FDA has a unique perspective on the…
Global Medical Device Industry Report
Association Of Indian Medical Devices Industry
Trends and segments for medical devices in the EU market
In most EU countries a tendency can be observed towards a decrease in the number of hospital beds, which is partly achieved by reducing the average length of stay of a patient in a hospital. As a result, homecare trea…
Trends and segments for medical devices in the EU market
Industry has benefited from the accession of CEE countries
Association Of Indian Medical Device Industry
After years of trying to be heard the GHTF (Global Harmonising Task Force) has been disbanded. They had lots of good ideas about levelling the medical device regulatory playing field but national interests have eventu…
Gujarat: Leading The Medical Device Sector In India
Some of the challenges faced by the companies when doing business in Gujarat is the lack of skilled manpower, over dependence on manual processes or lack of automation, high cost of power, increasing cost of manpower…
India, Canada To Launch R&D Projects In Biotech, Medical Devices
Under the Canada-india Agreement for Scientific and Technological Cooperation aimed at fostering joint Research and Development (R&D) projects, the two sides will launch R&D projects in all areas of biotechnology incl…
PC Working Group Recommends Rs. 6256 Cr To Strengthen Drug Regulatory System
The Working Group of the Planning Commission (PC) on drugs has recommended a total financial outlay of Rs. 6256 crore for strengthening the drugs and regulatory system, including that in the states and creation of a s…
Pharmaceuticals export promotion council
(Set up by Ministry of Commerce & Industry, Govt. of India)
Stanford Brings Affordable Medical Innovation To India Through Collaborative Design
A BONE DRILL is a nasty-sounding device that looks like something you'd find on the shelf at Home Depot. You wouldn't want to see one coming at you, but if you needed one, you'd likely be in such bad shape that you wo…
Global Forum Calls For Strategies On Medical Devices
The first Global Forum on Medical Devices organised by the World Health Organisation (WHO) in Bangkok in the second week of September, has emphasised the need for appropriate evaluation, prioritization, regulation, as…
BD Looking For New Growth Avenues In Emerging Markets, And India
The company, having established its plant in 1995 in India is looking for new growth avenues in emerging markets, and India. Its first office in the country was set up in 1995. BD’s India revenues, which topped $100 m…
Requirements For The Regulatory Control Of Medical Devices In India
In India import, manufacturing, sale and distribution of Medical devices is regulated under Drugs and Cosmetics Act and Rules. At present, Medical Devices notified by Central Government are regulated under the said Ac…
Medical Device Regulations
system requirements A Quality System is defined as the organizational structure, responsibilities, procedures, processes and resources needed to implement quality management. Quality system standards are “generic mana…
Ahmedabad Likely To Get First National Medical Device Centre
The $2-billion Indian medical device sector is set to get a push with the Centre considering setting up the country’s first National Centre for Excellence for Medical Devices in Ahmedabad.
Aptar Pharma gears up to increase presence in India with a range of nasal & pulmonary devices
Aptar Pharma India Pvt Ltd, a drug delivery device major is gearing up to increase its market presence in the country with its range of pulmonary and nasal drug dispensing products.
Association of Indian Medical Device Industry
Standards Up-date BS EN Publications BS EN 455:- Medical gloves for single use. BS EN 455-4:2009 Requirements and testing for shelf life determination.
Centre Makes Use Of Auto Disable Syringes Mandatory In Govt. Hospitals From April 2009
The action came in the wake of nationwide study conducted by the IndiaCLEN Program Evaluation Network on behalf of the Ministry of Health and World Bank, entitled ‘Assessment of Injection Practices in India’ in 2002-0…
Commerce Ministry Extends DEPB Scheme Withdraws Reduction In DEPB Rates
Owing to the tremendous pressure exerted by the exporting community in the country, the Union commerce ministry has extended the DEPB (duty entitled passbook) scheme till December 31, 2009. Moreover, the ministry has…
DCGI Discontinues WHO-GMP Certification
The Drugs Control Society of India (DCGI) has taken a decision to discontinue issuance of WHO-GMP certificate for both pharma products and plant audits. The decision comes in the wake of objection raised by the World…
DCGI Office Confuses Exporters Over Issuance Of WHO-GMP Certificate
Utter confusion and lack of coordination seem to prevail in the office of DCGI over the issuance of WHO-GMP certificates for the exporters. While DCGI Dr Surinder Singh categorically stated some days ago that there is…
Ethicon introduces new packaging for Biopatch to improve ease of application for patients with catheters
Ethicon, Inc, a Johnson & Johnson Company, announced that Biopatch Protective Disk with CHG (chlorhexidine gluconate) will include new design elements and updated packaging to make it easier for surgeons, nurses and o…
Separate Norms For Medical Devices Soon
The government has decided to bring separate quality guidelines for medical devices such as stents, catheters, orthopaedic implants and heart valves by end of May.
US FDA Alerts Healthcare Professionals Not To Share Insulin Pens & Cartridges
The US Food and Drug Administration issued an alert to health care professionals reminding them that single-patient insulin pens and insulin cartridges should not be used to administer medication to multiple patients…
Zonal Offices of CDSCO May Be Grated Powers For Issuing Licences Under CDA
The Centre may tone down the much-criticised provision of issuing manufacturing licences only by a cetralised agency based in Delhi under the proposed Central Drug Authority of India, by empowering the zonal offices o…
European Medical Device Vigilance System Guidelines
The European Medical Device Vigilance System Guidelines version #5 provides clear guidelines for application with lawful directives (AIMD-Article 8, MDD-Article 10, IVDD-Article 11), explains the salient purposes of t…
India To Witness Higher Growth In Pharma In Next 5 Years: Expert
In his special address in the inauguration of 'Pharmaceuticals: Market Prognosis - 2012', seminar organized by Federation of Indian Chambers of Commerce and Industry (FICCI), he said that while the top 10 companies in…
Asian Healthcare Sector To Beat US
The combined incremental demand for healthcare, in dollar terms, in five Asian countries - China, India, Japan, Korea and Singapore could exceed the US by 2015, led by rising income, increased medical tourism and agei…
CCE Software develops two new solutions for Pharma ERP and Medical Rep Management
Welch Allyn, a leading global manufacturer of medical diagnostic equipment and a complete range of digital and connected solutions, announced that the company has launched a new range of FlexiPort blood pressure cuffs…
Centre allots Rs 630 cr for medicinal plants cultivation covering one lakh hectares
About one lakh hectares of land will be covered under medicinal plants through direct financial assistance by the year of 2011-12 under the centrally-sponsored scheme of national mission on medicinal plants at a total…
Conference Theme For Next Delhi IPC: “Regulation For Better Healthcare”
The next Indian Pharmaceutical Congress (IPC), scheduled to be held in Delhi from December 12 to 14 under the aegis of Indian Pharmacy Graduate Association (IPGA), will have ‘Pharma Vision 2020: Regulations for better…
DCGI to establish multi-level complaint redressal system to address industry grievances
The Drug Controller General of India (DCGI) will soon put in place a multi-level complaint redress mechanism including a grievances box to be manned and opened personally, in a bid to mitigate the irritants of the ind…
India Can Emerge As Med Equipment Mfg Hub Soon
Experts in the medical equipments are of the view that India can emerge as an alternative destination to China in the field of medical equipment and devices manufacturing if the central government extends the right im…
India To Emerge Leading Pharma Market Of The World
Indian pharmaceutical industry, which has grown at 1.5 to 1.6 times the growth of the economy over the past couple of years, is well positioned for sustainable growth and expansion. The industry has grown at a CAGR of…
Marck To Enter Malaysia, S’pore & Indonesia Markets
The Ahmedabad based Pharmaceutical company Marck Biosciences Ltd. is all set to foray into the Far East countries like Malaysia, Singapore and Indonesian markets by the end of June 2008. The company is planning to off…
Medical Devices Regulation Bill Proposes Penalty Provisions Against Defaulters
The draft Medical Devices Regulation Bill, 2006, aimed at regulating the medical devices market, has proposed for classification of devices in relation to the risks and penalties for non-compliance with safety, regist…
Medical Equipment Cos Ask Govt To Bring Down Import Duty To 5% In Union Budget
Medical equipment manufacturers and providers have jointly sought a reduction in import duty on medical equipments in the Union Budget 2008-09 for the benefit of industry and patients.
Productivity Council finds 40% SSI units shut due to enforcement of GMP norms
To make the inspections and other related activities in the country more frequent and foolproof, the US FDA may soon establish its offices in Delhi, Mumbai and Hyderabad in India. According to sources, the proposal to…
US FDA revises communication regulation to drug companies on applications
(Ref: Chronicle Pharmabiz dated 12 July 2008)
Electrical Device For Welding Human Tissue Approved For Surgical Use In Russia
Ukraine based company, International Association Welding (IAW), has adapted welding technology to bond human tissue in surgery. Without the use of adhesive materials like sutures, staples, sealant or glue, the tissue…
FDA Report Urges Guidelines For Nanotechnology Products
The US Food and Drug Administration (FDA)'s Nanotechnology Task Force has released a report that recommends the agency consider developing guidance and taking other steps to address the benefits and risks of drugs and…
IN-XS Introduces Carboxy Pen Therapy For Obesity
IN-XS, a Bangalore-based anti-aging and anti-obesity clinic, has introduced carboxy pen therapy, a US FDA approved treatment modality for fat reduction. Carboxy pen therapy is safe, simple, painless and an effective p…
Surgical Drapes, Gowns And Gloves Markets In Europe
Rising Awareness of Nosocomial Infections and Increase in Surgical Procedures Drive Demand for Surgical Drapes, Gowns and Gloves The European surgical drapes, gowns and gloves markets are moving slowly toward maturity…
Centralised Licensing With Inadequate Staff May Lead To Delay In Granting Product Licences
Pharmaceutical companies in the country may have to cope with serious delays in getting their applications for drug licenses cleared once Central Drugs Authority (CDA) of India is formed. Such delays in the initial ph…
Centre Plans Authority To Regulate Collection, Storage Of Blood
The Central government is planning to create a regulatory framework called Blood Transfusion Authority on the lines of FDA to monitor various aspects like blood collection, storage and distribution. A suitable legisla…
DBT Invites Joint Proposals From Indian, German Scientists
In order to facilitate collaborations between Indian and German scientists, the Department of Biotechnology (DBT) has invited proposals in the area of biotechnology under the national funding programme.
Fresenius Kabi India On Expansion Spree
Fresenius Kabi India, a wholly-owned subsidiary of Germany-based Fresenius Kabi, has decided to aggressively expand its operation both through organic and inorganic routes. The more than Rs 100-crore company, based in…
Fresenius Medical Picks Up Majority Stake In Taiwanese Dialysis Firm
Fresenius Medical Care AG & Co. KGaA continues to expand in Asia. The company announced the acquisition of a 51 per cent equity interest in Jiate Excelsior Co. Ltd. (Excelsior) in Taiwan. With a market share of approx…
Govt Plans Regulation Of Retail Pharmacies
The government is planning to tighten the norms for transporting, storing and selling medicines in the country even as big corporate houses are opening retail pharmacy chains and the existing ones get corporatised.
Indian Pharma Machinery Makers Go For Overseas Tie-Ups For Growth
The pharmaceutical machinery manufacturing industry in the country, with more than 600 players of various sizes, is all set for a major boom with several domestic players prefer to either set up a joint venture compan…
IPR Comes With New Hi-tech Medical Waste Disposable Plan For Hospitals
Hospitals may soon be able to dispose off medical wastes in an eco-friendly manner using a new technology.
Jubilant Organosys Bags Golden Peacock Global Award 2007
Jubilant Organosys has bagged the coveted Golden Peacock Global Award (2006-07) for "Excellence in Corporate Governance". The award is given by the World Council for Corporate Governance, UK, annually, to companies th…
Labelling Committee Moots Country Wise Code For Drug Exports
The sub committee for labeling of drugs set up by DCGI is considering to incorporate a country wise code number on the labels of exporting products to ensure quality compliance and perfection in each consignment. The…
Legislation Promotes Healthcare IT Infrastructure and Patient Data Safety across Europe
Legislation is promoting the development of healthcare IT infrastructure, while supporting efforts to enhance patient data privacy and security across the European healthcare spectrum.
Marck Biosciences In Talks With US Cos For Site Transfer
Marck Biosciences is talking to several US based pharma companies for a site transfer deal, through which it can undertake contract manufacturing of small volume parenterals and injectibles at its facility in Gujarat.
Marck Biosciences Plans Global Expansion
Aimed to achieve the target turnover of Rs 100 crore in 2007-08, the Ahmedabad-based Marck Biosciences Ltd, a leading manufacturer of parenterals, said the company would expand its presence in global markets.
Medical Devices Being Marketed Without Regulations, Safeguards In India
India still does not have a comprehensive set of rules for the manufacture and marketing of medical devices despite their increasing therapeutic in human bodies for several years. The Central Drugs Standard Control Or…
Medical Devices Like Stents, Catheters May Be Notified As Drug
More medical devices may fall under the category of drug in the country as the subcommittee, formed to set up standards for 10 notified medical devices, plans to recommend the authority to notify devices including ort…
Philips Identifies India For Medical Equipment Biz
PHILIPS has identified India along with China and Japan to grow its medical equipment business in the Asia Pacific region.
US FDA Nod For Baxter's Colleague Infusion Pump
Baxter Healthcare Corporation has received clearance from the US FDA on its Colleague infusion pump 510(k) pre-market notification. The company is preparing to modify pumps currently in the market and will soon submit…
World's 1st 3D ICU Ventilator Launched
Trivitron, in association with Hamilton Medical AG, a Swiss manufacturer of 'intelligent ventilators' launched Hamilton G5, world's first 3D ICU ventilator in India. The new Hamilton G5 ICU ventilator is focused on im…
US FDA Proposes To Set Up Internal Nanotechnology Task Force
The US Food and Drug Administration (FDA) has proposed formation of an internal FDA Nanotechnology Task Force. The new Task Force is charged with determining regulatory approaches that encourage the continued developm…
New Technology To Deal With Swelling Of Arteries
There is a completely new technology arriving to deal with aneurysm (swelling) of the arteries. This relates to implanting a PTFE covered stent in the affected artery to block off the flow of blood into the aneurysm.…
China Exports 70% of Its Medical Devices To US, Japan and Germany
The gross output value of China's medical instrument industry maintained a rapid growth since 1990s with an average annual growth rate of 12-15 per cent. China's domestic medical device manufacturing is largely domina…
European Cardiology Imaging Markets
to Benefit from Introduction of Comprehensive Packages with Enhanced Cross-departmental Workflow Integration and Multi-modality Interoperability
European IV Therapy and Enteral Nutrition Market
Increasing Incidence of Diseases Revives the European IV Therapy and Enteral Nutrition Market
European Non-Invasive Ventilators and Interfaces Market
Innovative Interfaces Key to Maintaining Revenues in European Non-Invasive Ventilators and Interfaces Market
European Patient Administration Systems Markets
Potential for Integrated Healthcare, Streamlined Workflows and Improved Administrative Efficiency Motivate Uptake of Patient Administrative Systems
Opportunities for Medical Devices in Eastern Europe
Admittance into the EU Presents New Growth Opportunities in Eastern European Medical Devices Markets
Axa Sets Up IV Fluids Facility At Roorkee
Axa Parenterals Ltd. is setting up a new sterile manufacturing facility at Roorkee in Uttaranchal for manufacturing sterile formulations. The plant will start production within two-three months.
Centre Extends Application Deadline For Import, Registration of Medical Devices to June 29
The Union ministry of health and family welfare, which came out with the guidelines for licensing of import and manufacture of medical devices with a deadline of sixty days with effect from March 1, 2006, has now post…
Govt To Spend Rs 360 Cr On Health Regulator
National Drug Authority, Modelled On USFDA, To Improve Quality Of Drugs & Clinical Trials
Health Ministry's Guidelines For Import, Manufacture of Medical Devices Effective From March 1
The Union ministry of health and family welfare has come out with the guidelines for licensing of import and manufacture of medical devices in India. The guidelines for the devices including Cardiac Stents, Drug Eluti…
Imported Non-Sterile Medical Devices Meant For Sterile Use Need Mandatory Registration
The Central Drugs Standard Control Organisation (CDSCO) has made it clear that all imported non-sterile medical devices, if meant to be used as sterile devices in the country, are subjected to mandatory registration.…
India, Germany Plan Mutual Recognition of GMP Certification
India is likely to sign an agreement with Germany on mutual recognition of Good Manufacturing Practices (GMP) certification for drug manufacturing units. A high level delegation is currently on a visit to Germany to w…
India's First Indigenous Drug Eluting Stent Receives CE Approval
Sahajanand Medical Technologies (SMT) has received CE approval (Conformité Européenne), an authorisation certificate, for qualification for the sale of Infinnium in European community and many other countries in the w…
Medical insurance is growing at a clip of 30% a year but further opening of the sector to foreign direct investment and a tariff-free regime may well provide a booster dose
Until about five year ago, PSUs were offering health insurance as part of their product portfolio under the brand name Mediclaim. With the government opening up the sector to private players, such companies as ICICI,…
MV Hospital Completes Study of Low Cost LCT Device
The Chennai based MV Hospital for Diabetes and Diabetes Research Centre has completed clinical study on a low cost Liquid Crystal Thermography (LCT) device, evolved in the research collaboration between the UK based B…
NABH Plans Quality Standards For Blood Banks, Medical Imaging Services
The National Accreditation Board for Hospital & Healthcare Providers (NABH), set up by Quality Council of India (QCI), is planning to extend its services into the accreditation of blood banks, medical imaging services…
NBI To Begin Testing of Medical Devices
Even as the government directives for the quality testing of medical devices that were recently notified as drugs are yet to materialize, the National Institute of Biologicals (NBI), Noida, has announced its intention…
"Regulation Will Help Growth of Medical Devices Sector In India"
In an interview with Nandita Vijay of Chronicle Pharmabiz, Milind Shah provides an overview of the sector and says that regulatory approval for medical devices has to be made mandatory in India. Excerpts:
Too Many New Medical Devices Leave Doctors At Sea
Last Summer, rival cardiologists in Rock Hill, South Carolina, decided to learn how to perform a lucrative new procedure, implanting a defibrillator, a device that protects against fatal heart rhythms.
UL Pitching To Be India's Authorised Certification Company For Medical Devices
The Centre has initiated a dialogue with certification organisations including UL India Private Limited, an affiliate of the US based underwriters Laboratories Inc, for appointing an authorised certification company f…
US FDA To Join PIC/S To Help In Harmonisation of GMPs
The United States Food and Drug Administration (FDA) have applied for a membership with the Pharmaceutical Inspection Cooperation Scheme (PIC/S), an international initiative to harmonise GMP standards. This is part of…
BARC Develops Alternative To Holmium For RA Therapy
The Board of Radiation and Isotope Technology (BRIT), a branch of BARC, has developed p-32, an alternative to holmium (ho-166), a radiopharmaceutical used in Radiation Synovectomy for rheumatiod arthritis. BRIT sugges…
FDA Has Always Required Hospitals To Report and Identify Adverse Events Attributable to Reprocessed Devices
FDA has always required that hospitals notify the agency when a reprocessed device was involved in adverse events associated with death or serious injury.
Fundamental differences between drugs and medical devices
The table below comparing pharmaceuticals and medical devices is aimed at emphasizing the key differences between the two types of products, which explain and justify a differentiated regulatory approach
Medical Device Reprocessing
We reproduce abstracts of a recent debate regarding use of reconditioned medical devices highlighted by "Washignton Post " under the heading , "Hospitals Save Money, But Safety Is Questioned " . The Association of Med…
The Post Does a Disservice to Patients By Instilling Panic Through Outdated or Irrelevant Examples
(Washington, D.C.) December 12, 2005 -- A year-long Washington Post investigation into the widely-used practice of reprocessing medical devices found no evidence that patients are put at an increased risk from the pra…
AMO To Launch New Ophthalmic Products In India
Advanced Medical Optics India Pvt. Ltd, the Indian arm of the US-based global ophthalmic medical device leader, Advanced Medical Optics Inc. (AMO), is expanding its market presence in India by launching new products a…
Auto Disable Syringes : Hindustan Medical Devices (HMD) Tie Ups With Pharma Multinationals
Hindustan Medical Devices (HMD), the lone domestic manufacturer of auto disable (AD) syringes, is currently on a deal signing spree with many of the pharma multinationals and some of the domestic pharma companies for…
Cardiac Stents Without Approval
Recent media reports about the use of unapproved cardiac stents on heart patients in Mumbai's JJ Hospital have brought to light the pathetic state of regulatory control on medical devices in the country. Maharashtra F…
Diagnostic Reagents And Kits : GMP Norms
The diagnostic reagents and kits manufacturers of the country will soon have to comply with a fresh set of Good Manufacturing Practices norms being finalised by the central government. The GMP norms will specify the r…
DTAB Nod On Medical Device Control On August 2
The Central Government is likely to bring in amendments to Drugs and Cosmetic Rules within three months to arm the Central Drugs Standard Control Organisation (CDSCO) to regulate the entire range of medical devices ma…
EU Model Systems For Medical Devices With BIS Fixing Approval Standards
The Central Government is likely to come out with a European Union model regulatory system for medical devices that are manufactured or marketed in the country. The highlight of the proposed system is that it will ent…
Fresenius to invest Rs 10 crore in Pune Facility
Fresenius Kabi India Pvt Ltd, a wholly owned subsidiary of Fresenius Kabi AG, Germany, is planning to increase its presence in the country in a big way. The company is in the process of upgrading its manufacturing fac…
Fresenius To Upgrade I.V. Fluid Units To European Standard
Fresenius Kabi, the European leader in infusion and nutrition therapy, which has strong market presence in emerging markets including India, would upgrade its manufacturing facilities all across the world to European…
GE Healthcare Launches High Definition Magnetic Resonance (HDMR) System In India
GE Healthcare, a division of General Electric Company, launched in India the High Definition Magnetic Resonance (HDMR) system. This breakthrough technology, which was introduced in the US in December 2004, features fi…
'Half Of The Drug Eluting Stents Used In India Lack Adequate Trial Data'
Maharashtra FDA’s recent decision to ban Drug Eluting Stents (DES) without international quality certifications stirred up a controversy in the country on the safety and quality aspects of DES used in the country. Inc…
India to outrun China in 15 years : Deutsche Bank study
Over two millions people will be participating in clinical studies in India by that time.
Mah FDA Order May Hit Domestic Stent Makers
The Maharashtra government's directive making it mandatory for manufacturers of drug eluting stents (DES) to produce USFDA and CE certification to market their products in the state will hit Indian manufacturers badly…
Medical Architecture : IIA Forming Standardised Guidelines
Just when experts are propagating the importance of accreditation and standardisation of healthcare institutes, the Indian Institute of Architects (IIA) has mooted the proposal of forming standardised guidelines in me…
Medical Packaging : DuPont P&IP to market authentication technologies
Health Ministry plans 50 testing labs in 3 years The Ministry of Health & Family Welfare has launched a major initiative to set up 50 state-of-the-art drug testing laboratories across the country within three years. W…
Medtronic To Market Endeavor DES in India
Medtronic has received CE Mark (Conformité Européenne) approval fro the commercial sale of the Endeavor DE Coronary Stent with the Rapid Exchange Delivery System. Endeavor is claimed to be the first Cobalt Alloy drug…
NGO Launches Nationwide Campaign Against Unapproved Medical Devices
Public Response Against Helplessness and Action for Redressal (PRAHAR), a Delhi based non-governmental organisation, has launched a multi-city campaign 'Making Cardiac Care Fair' against implant of 'life threatening i…
Nirma acquires Core Healthcare's IV fluids business
ARCIL a securitisation and reconstruction company acquired 60 per cent (Rs 380 crore) of CHL's total borrowing of Rs 650 crore (principal amount) about a year and a half ago. The sale is, however, subject to approval…
Nirma Close To Sealing Core Deal
Seven months after it announced its intent to acquire ailing Ahmedabad based Core Healthcare's intravenous fluids and medical devices business, FMCG major Nirma is learnt to be close to be wrapping up the deal for a l…
Paramedical & Physiotherapy Councils Bill - 2004 : Physiotherapists Find Not Acceptable
Opposing Government's initiative to club physiotherapy with paramedical council, physiotherapists across the country have demanded a "Physiotherapy Council of India".
Sterilization Plant For Medical Products Ready To Take Off
Maharashtra's first and Indai's second Gamma radiation sterilization plant in the private sector, for radiation sterilization of medical products and spices coming up at Ambernath in Thane district of Maharashtra, wil…
What are the basic matters that have to be considered while framing the rules to regulate stents?
The device should go through safety animal data, human safety trials, efficacy trials and should be submitted to the regulatory authority seeking approval. The regulatory authority must check the data and decide wheth…
Bar Code Technology For Healthcare Sector
EAN India is on an aggressive drive to educate the healthcare sector to implement EAN UCC (uniform code council) standards, which insists on use of bar codes to minimize errors in patient care. The cost of implementin…
Docs See jackpot in medical tourism
You don’t need to break a hip to come to India.
For Sector To Take Off, Legislation And Infrastructure Need To Be In Place Medical tourism can spin a dollar dream
It is tourism with a difference: healthcare or medical tourism. This is an area that Indian can have an edge in provided it is developed well. According to a McKinskey report, medical tourism can fetch up to $2bn. How…
Govt. to keep a close watch, on healthcare delivery
CONSUMERS can now hope to get better quality treatment as hospitals across the country would soon be required to adhere to some common basic quality standards for healthcare delivery. After months of rhetoric, the gov…
Indian Healthcare Federation (IHFC) To Launch Country's First Accreditation System For Healthcare Institutions
Indian Healthcare Federation (IHCF). The apex body of healthcare service providers in India, is about to launch the country's first accreditation system for healthcare institutions. IHCF is working closely with US bas…
Law For Medical Devices
Secondly, a registry of all medical devices and equipments available in the market should be prepared. There is no such list of the number and type of products with the government. A key responsibility of the new regu…
GE Medical Systems launches fastest functional imaging workstation
GE Medical Systems South Asia has introduced Xeleris, one of the industry’s fastest functional imaging workstation available in the world. Xeleris is designed to become the productivity hub of nuclear medicine and pos…
Govt plans IT standards for healthcare units
ACCESS to quality healthcare in rural areas could soon be a reality if a new government initiative fructifies. The ministry of communications and IT is in the process of developing standards for digital information ac…
Hospital Consultancy And Management : Apollo Hospitals Spreading Wings
Corporate healthcare major Apollo Hospital is steadily spreading its wings across projects management. The focus is on project consultancy and management of a hospital, promoted by other parties. Apollo Hospitals play…
Implantable device to help monitor organ function
Health experts are of the opinion that tiny implantable devices may be used to track organ function in the near future.
Indian Healthcare Industry: Rising change In Attitude By Middle Class
ARISING middle in come group and a change in attitude to-wards healthcare is driving the growth in the Indian healthcare industry.
Ischemia Albumin Blood (IMA) Test : USFDA Clearance To Market The Albumin Cobalt Binding (ACB) Test
Pharmacopoeia Commission to be set THE long-awaited Indian Pharmacopoeia Commission (IPC) is likely to come into being in April. The health ministry has moved a Cabinet note proposing setting up the IPC with an initia…
Medical Tourism : Hospitals, Maharastra State Govt Team Up To Lure Medical Tourists
Dengue Detection Kit : CHPL tie-up with Panbio, a world leader in dengue detection kits CHPL has a tie-up with Panbio, a world leader in dengue detection kits, and is the first company in India to make available the k…
Stents : Quality Control Is A Must (A Report By the Forum For Medical Ethics )
A forum for Medical Ethics study indicates that a frighteningly large number of doctors makes their prescriptions based on kickbacks rather than quality. The government, meanwhile, does not even pretend to regulate th…
UL India offers safety certification for equipment vendors
. UL India, an affiliate of Underwriters Laboratories Inc. (UL Inc., USA) is confident that, by the end of this year, at least 50 medical equipment vendors would utilize its services in certification for product safet…
Unicondylar Arthroplasty : A New Technique of Surgery For Knee Joint
The joint replacement surgery unit (JRSU) at the Civil Hospital, Ahmedabad, India has introduced Unicondylar Arthroplasty – a new technique of surgery – which requires changing of only a part of knee joint for early o…
Industry News Page 2 of 2
ENGINEERING and construction conglomerate, Larsen & Toubro (L&T) has decided to tap the global medical equipment market in a big way. This would be achieved mainly through offering contract manufacturing to foreign co…
TTK Healthcare plans to export artificial heart valves
Chennai-based TTK Healthcare Ltd, part of the diversified TTK Group, buoyed by the encouraging performance of TTK-Chitra Heart Valve Prosthesis in the domestic market, is now firming up plans to export these heart val…
Industry News Page 1 of 2
India needs to step up its efforts in the field of healthcare by improving the state of its medical equipment, instruments, devices and software, according to the Confederation of Indian Industry. The summit, with Ger…
Industry News Page 2 of 2
The Mohali-based Adonis Medical Equipments Pvt Ltd plans to launch its new product C-Arm by the end of the year. It aims to bring different types of products with conventional technology (economical) and high frequenc…
Industry News Page 2 of 2
Innoval Medical India, a Chennai-based blood bag manufacturer, is planning to come out with its Initial Public Offer (IPO) shortly. The company has proposed to enter into production of intravenous and blood transfusio…
Industry News Page 2 of 2
Apollo Hospitals group is forming a joint venture with Parkway Hospitals group of Singapore to set up psuper-speciality hospitals outside India and Singapore. Apollo Hospitals group chairman Prathap C Reddy said that…
About Humanitarian Use Medical Devices (HUDs)
On June 26, 1996, FDA issued a final rule to carry out provisions of the Safe Medical Devices Act of 1990 regarding humanitarian use devices (HUDs). An HUD is a device that is intended to benefit patients by treating…
Understanding Europe's New Medical Device Regulation - MDR 2017/745
What are the key changes of the regulation?
Medical Devices That Use Breathing Gas Pathways, Like Oxygen Masks, Can Pose Risks To Patients?
Air from the device and its parts can enter the patient's breathing passageways, exposing internal tissues to chemical emissions and condensates. Patients receiving supplemental oxygen can expose others to exhaled air…
Landmark Public-Private Partnership MoU Inked
AiMeD & Invest India sign a momentous MoU aimed at making India a global manufacturing hub for medical devices and components
Centre To Notify Revised Schedule M III For Medical Devices By June End
Following strong representation from the medical devices industry, the Centre has agreed to align Schedule MIII with IS/ISO 13485 by delinking it from Schedule M for Pharma. The revised Schedule MIII will be notified…
Separate Rules To Spur Medical Devices Sector Soon
In lines with the prime ministers ‘Make in India Campaign’, the department of industrial policy and promotion (DIPP) has identified medical devices as one among the top five sectors having good investment potential in…
China: Medical Technology Potentials Are Enormous
Health Industry Summit (CMEF) in Shanghai opens path to Chinese market, features products for global distribution.
100% FDI for Medical Devices Under ‘Automatic Route’ Now
The government has now allowed 100 per cent FDI under automatic route in medical devices sector to encourage manufacturing of equipments, including diagnostic kits and other devices. “Easing of norms for medical devic…
ASEAN Countries Could Be The Next Emerging MedTech Markets
Thanks to a large population, rising middle class, and increasing healthcare spending, the 10 countries that make up the Association of Southeast Asian Nations are gaining attention from medical device makers.
Experts Miffed Over Delay In NIPER Campus In Gandhinagar
Even after almost seven years since it received the Union Cabinet nod and land allotment by the state government, the National Institute of Pharmaceutical Education and Research (NIPER) campus at Gandhinagar in Gujara…
Key Country Assessments
Thailand : With a population of 67 million Thailand shares borders with Malaysia, Burma, Laos, and Cambodia. Per-capita healthcare spending in Thailand increased from $73 in 2002 to approximately $220 in 2013. The gov…
Pharmexcil to establish warehousing facility in Nigeria
The Pharmaceuticals Export Promotion Council of India (Pharmexcil), is planning to establish a warehousing facility in Nigeria to support Indian exporters in Africa.
D&C Rules On Labeling Norms, Shelf Life Of Medical Devices
The Centre is expected to further streamline the medical devices sector by suitably amending the norms on labeling, qualification for supervision of manufacturing of devices, quality standards and shelf life under the…
Design Clinic Scheme For Medical Devices Industry by NID (National Institute of Design)
Medical Devices being one of the important sectors with high potential for import substitute and exports, MSMEs in India have been able to achieve great success in creating breakthrough products.
Life Sciences And Medical Devices Sector In India: Highlights
(Sector Highlights By Frost And Sullivan Prepared For Panel Discussion On “Right Opportunities And Best Practices In BRIC Markets”)
China's Packaging Industry Luring Indian Companies
Indian Pharma Industry Keen On Innovative Packaging
Pharmexcil To Sign MoU With Japanese Industry Association Soon For Furthering Export Trade
The Pharmaceutical Export Promotion Council of India (Pharmexcil) is planning to sign a Memorandum of Understanding (MoU) with the Japanese pharma industry association with an aim to further improve India’s export tra…
Driving Biomedical Innovation : Initiatives To Improve Products For Patients
Because of its role as both a regulator and as a public health agency facilitating the development of new, innovative products to meet the needs of patients and the American public, FDA has a unique perspective on the…
Global Medical Device Industry Report
Association Of Indian Medical Devices Industry
Trends and segments for medical devices in the EU market
In most EU countries a tendency can be observed towards a decrease in the number of hospital beds, which is partly achieved by reducing the average length of stay of a patient in a hospital. As a result, homecare trea…
Trends and segments for medical devices in the EU market
Industry has benefited from the accession of CEE countries
Association Of Indian Medical Device Industry
After years of trying to be heard the GHTF (Global Harmonising Task Force) has been disbanded. They had lots of good ideas about levelling the medical device regulatory playing field but national interests have eventu…
Gujarat: Leading The Medical Device Sector In India
Some of the challenges faced by the companies when doing business in Gujarat is the lack of skilled manpower, over dependence on manual processes or lack of automation, high cost of power, increasing cost of manpower…
India, Canada To Launch R&D Projects In Biotech, Medical Devices
Under the Canada-india Agreement for Scientific and Technological Cooperation aimed at fostering joint Research and Development (R&D) projects, the two sides will launch R&D projects in all areas of biotechnology incl…
PC Working Group Recommends Rs. 6256 Cr To Strengthen Drug Regulatory System
The Working Group of the Planning Commission (PC) on drugs has recommended a total financial outlay of Rs. 6256 crore for strengthening the drugs and regulatory system, including that in the states and creation of a s…
Pharmaceuticals export promotion council
(Set up by Ministry of Commerce & Industry, Govt. of India)
Stanford Brings Affordable Medical Innovation To India Through Collaborative Design
A BONE DRILL is a nasty-sounding device that looks like something you'd find on the shelf at Home Depot. You wouldn't want to see one coming at you, but if you needed one, you'd likely be in such bad shape that you wo…
Global Forum Calls For Strategies On Medical Devices
The first Global Forum on Medical Devices organised by the World Health Organisation (WHO) in Bangkok in the second week of September, has emphasised the need for appropriate evaluation, prioritization, regulation, as…
BD Looking For New Growth Avenues In Emerging Markets, And India
The company, having established its plant in 1995 in India is looking for new growth avenues in emerging markets, and India. Its first office in the country was set up in 1995. BD’s India revenues, which topped $100 m…
Requirements For The Regulatory Control Of Medical Devices In India
In India import, manufacturing, sale and distribution of Medical devices is regulated under Drugs and Cosmetics Act and Rules. At present, Medical Devices notified by Central Government are regulated under the said Ac…
Medical Device Regulations
system requirements A Quality System is defined as the organizational structure, responsibilities, procedures, processes and resources needed to implement quality management. Quality system standards are “generic mana…
Ahmedabad Likely To Get First National Medical Device Centre
The $2-billion Indian medical device sector is set to get a push with the Centre considering setting up the country’s first National Centre for Excellence for Medical Devices in Ahmedabad.
Aptar Pharma gears up to increase presence in India with a range of nasal & pulmonary devices
Aptar Pharma India Pvt Ltd, a drug delivery device major is gearing up to increase its market presence in the country with its range of pulmonary and nasal drug dispensing products.
Association of Indian Medical Device Industry
Standards Up-date BS EN Publications BS EN 455:- Medical gloves for single use. BS EN 455-4:2009 Requirements and testing for shelf life determination.
Centre Makes Use Of Auto Disable Syringes Mandatory In Govt. Hospitals From April 2009
The action came in the wake of nationwide study conducted by the IndiaCLEN Program Evaluation Network on behalf of the Ministry of Health and World Bank, entitled ‘Assessment of Injection Practices in India’ in 2002-0…
Commerce Ministry Extends DEPB Scheme Withdraws Reduction In DEPB Rates
Owing to the tremendous pressure exerted by the exporting community in the country, the Union commerce ministry has extended the DEPB (duty entitled passbook) scheme till December 31, 2009. Moreover, the ministry has…
DCGI Discontinues WHO-GMP Certification
The Drugs Control Society of India (DCGI) has taken a decision to discontinue issuance of WHO-GMP certificate for both pharma products and plant audits. The decision comes in the wake of objection raised by the World…
DCGI Office Confuses Exporters Over Issuance Of WHO-GMP Certificate
Utter confusion and lack of coordination seem to prevail in the office of DCGI over the issuance of WHO-GMP certificates for the exporters. While DCGI Dr Surinder Singh categorically stated some days ago that there is…
Ethicon introduces new packaging for Biopatch to improve ease of application for patients with catheters
Ethicon, Inc, a Johnson & Johnson Company, announced that Biopatch Protective Disk with CHG (chlorhexidine gluconate) will include new design elements and updated packaging to make it easier for surgeons, nurses and o…
Separate Norms For Medical Devices Soon
The government has decided to bring separate quality guidelines for medical devices such as stents, catheters, orthopaedic implants and heart valves by end of May.
US FDA Alerts Healthcare Professionals Not To Share Insulin Pens & Cartridges
The US Food and Drug Administration issued an alert to health care professionals reminding them that single-patient insulin pens and insulin cartridges should not be used to administer medication to multiple patients…
Zonal Offices of CDSCO May Be Grated Powers For Issuing Licences Under CDA
The Centre may tone down the much-criticised provision of issuing manufacturing licences only by a cetralised agency based in Delhi under the proposed Central Drug Authority of India, by empowering the zonal offices o…
European Medical Device Vigilance System Guidelines
The European Medical Device Vigilance System Guidelines version #5 provides clear guidelines for application with lawful directives (AIMD-Article 8, MDD-Article 10, IVDD-Article 11), explains the salient purposes of t…
India To Witness Higher Growth In Pharma In Next 5 Years: Expert
In his special address in the inauguration of 'Pharmaceuticals: Market Prognosis - 2012', seminar organized by Federation of Indian Chambers of Commerce and Industry (FICCI), he said that while the top 10 companies in…
Asian Healthcare Sector To Beat US
The combined incremental demand for healthcare, in dollar terms, in five Asian countries - China, India, Japan, Korea and Singapore could exceed the US by 2015, led by rising income, increased medical tourism and agei…
CCE Software develops two new solutions for Pharma ERP and Medical Rep Management
Welch Allyn, a leading global manufacturer of medical diagnostic equipment and a complete range of digital and connected solutions, announced that the company has launched a new range of FlexiPort blood pressure cuffs…
Centre allots Rs 630 cr for medicinal plants cultivation covering one lakh hectares
About one lakh hectares of land will be covered under medicinal plants through direct financial assistance by the year of 2011-12 under the centrally-sponsored scheme of national mission on medicinal plants at a total…
Conference Theme For Next Delhi IPC: “Regulation For Better Healthcare”
The next Indian Pharmaceutical Congress (IPC), scheduled to be held in Delhi from December 12 to 14 under the aegis of Indian Pharmacy Graduate Association (IPGA), will have ‘Pharma Vision 2020: Regulations for better…
DCGI to establish multi-level complaint redressal system to address industry grievances
The Drug Controller General of India (DCGI) will soon put in place a multi-level complaint redress mechanism including a grievances box to be manned and opened personally, in a bid to mitigate the irritants of the ind…
India Can Emerge As Med Equipment Mfg Hub Soon
Experts in the medical equipments are of the view that India can emerge as an alternative destination to China in the field of medical equipment and devices manufacturing if the central government extends the right im…
India To Emerge Leading Pharma Market Of The World
Indian pharmaceutical industry, which has grown at 1.5 to 1.6 times the growth of the economy over the past couple of years, is well positioned for sustainable growth and expansion. The industry has grown at a CAGR of…
Marck To Enter Malaysia, S’pore & Indonesia Markets
The Ahmedabad based Pharmaceutical company Marck Biosciences Ltd. is all set to foray into the Far East countries like Malaysia, Singapore and Indonesian markets by the end of June 2008. The company is planning to off…
Medical Devices Regulation Bill Proposes Penalty Provisions Against Defaulters
The draft Medical Devices Regulation Bill, 2006, aimed at regulating the medical devices market, has proposed for classification of devices in relation to the risks and penalties for non-compliance with safety, regist…
Medical Equipment Cos Ask Govt To Bring Down Import Duty To 5% In Union Budget
Medical equipment manufacturers and providers have jointly sought a reduction in import duty on medical equipments in the Union Budget 2008-09 for the benefit of industry and patients.
Productivity Council finds 40% SSI units shut due to enforcement of GMP norms
To make the inspections and other related activities in the country more frequent and foolproof, the US FDA may soon establish its offices in Delhi, Mumbai and Hyderabad in India. According to sources, the proposal to…
US FDA revises communication regulation to drug companies on applications
(Ref: Chronicle Pharmabiz dated 12 July 2008)
Electrical Device For Welding Human Tissue Approved For Surgical Use In Russia
Ukraine based company, International Association Welding (IAW), has adapted welding technology to bond human tissue in surgery. Without the use of adhesive materials like sutures, staples, sealant or glue, the tissue…
FDA Report Urges Guidelines For Nanotechnology Products
The US Food and Drug Administration (FDA)'s Nanotechnology Task Force has released a report that recommends the agency consider developing guidance and taking other steps to address the benefits and risks of drugs and…
IN-XS Introduces Carboxy Pen Therapy For Obesity
IN-XS, a Bangalore-based anti-aging and anti-obesity clinic, has introduced carboxy pen therapy, a US FDA approved treatment modality for fat reduction. Carboxy pen therapy is safe, simple, painless and an effective p…
Surgical Drapes, Gowns And Gloves Markets In Europe
Rising Awareness of Nosocomial Infections and Increase in Surgical Procedures Drive Demand for Surgical Drapes, Gowns and Gloves The European surgical drapes, gowns and gloves markets are moving slowly toward maturity…
Centralised Licensing With Inadequate Staff May Lead To Delay In Granting Product Licences
Pharmaceutical companies in the country may have to cope with serious delays in getting their applications for drug licenses cleared once Central Drugs Authority (CDA) of India is formed. Such delays in the initial ph…
Centre Plans Authority To Regulate Collection, Storage Of Blood
The Central government is planning to create a regulatory framework called Blood Transfusion Authority on the lines of FDA to monitor various aspects like blood collection, storage and distribution. A suitable legisla…
DBT Invites Joint Proposals From Indian, German Scientists
In order to facilitate collaborations between Indian and German scientists, the Department of Biotechnology (DBT) has invited proposals in the area of biotechnology under the national funding programme.
Fresenius Kabi India On Expansion Spree
Fresenius Kabi India, a wholly-owned subsidiary of Germany-based Fresenius Kabi, has decided to aggressively expand its operation both through organic and inorganic routes. The more than Rs 100-crore company, based in…
Fresenius Medical Picks Up Majority Stake In Taiwanese Dialysis Firm
Fresenius Medical Care AG & Co. KGaA continues to expand in Asia. The company announced the acquisition of a 51 per cent equity interest in Jiate Excelsior Co. Ltd. (Excelsior) in Taiwan. With a market share of approx…
Govt Plans Regulation Of Retail Pharmacies
The government is planning to tighten the norms for transporting, storing and selling medicines in the country even as big corporate houses are opening retail pharmacy chains and the existing ones get corporatised.
Indian Pharma Machinery Makers Go For Overseas Tie-Ups For Growth
The pharmaceutical machinery manufacturing industry in the country, with more than 600 players of various sizes, is all set for a major boom with several domestic players prefer to either set up a joint venture compan…
IPR Comes With New Hi-tech Medical Waste Disposable Plan For Hospitals
Hospitals may soon be able to dispose off medical wastes in an eco-friendly manner using a new technology.
Jubilant Organosys Bags Golden Peacock Global Award 2007
Jubilant Organosys has bagged the coveted Golden Peacock Global Award (2006-07) for "Excellence in Corporate Governance". The award is given by the World Council for Corporate Governance, UK, annually, to companies th…
Labelling Committee Moots Country Wise Code For Drug Exports
The sub committee for labeling of drugs set up by DCGI is considering to incorporate a country wise code number on the labels of exporting products to ensure quality compliance and perfection in each consignment. The…
Legislation Promotes Healthcare IT Infrastructure and Patient Data Safety across Europe
Legislation is promoting the development of healthcare IT infrastructure, while supporting efforts to enhance patient data privacy and security across the European healthcare spectrum.
Marck Biosciences In Talks With US Cos For Site Transfer
Marck Biosciences is talking to several US based pharma companies for a site transfer deal, through which it can undertake contract manufacturing of small volume parenterals and injectibles at its facility in Gujarat.
Marck Biosciences Plans Global Expansion
Aimed to achieve the target turnover of Rs 100 crore in 2007-08, the Ahmedabad-based Marck Biosciences Ltd, a leading manufacturer of parenterals, said the company would expand its presence in global markets.
Medical Devices Being Marketed Without Regulations, Safeguards In India
India still does not have a comprehensive set of rules for the manufacture and marketing of medical devices despite their increasing therapeutic in human bodies for several years. The Central Drugs Standard Control Or…
Medical Devices Like Stents, Catheters May Be Notified As Drug
More medical devices may fall under the category of drug in the country as the subcommittee, formed to set up standards for 10 notified medical devices, plans to recommend the authority to notify devices including ort…
Philips Identifies India For Medical Equipment Biz
PHILIPS has identified India along with China and Japan to grow its medical equipment business in the Asia Pacific region.
US FDA Nod For Baxter's Colleague Infusion Pump
Baxter Healthcare Corporation has received clearance from the US FDA on its Colleague infusion pump 510(k) pre-market notification. The company is preparing to modify pumps currently in the market and will soon submit…
World's 1st 3D ICU Ventilator Launched
Trivitron, in association with Hamilton Medical AG, a Swiss manufacturer of 'intelligent ventilators' launched Hamilton G5, world's first 3D ICU ventilator in India. The new Hamilton G5 ICU ventilator is focused on im…
US FDA Proposes To Set Up Internal Nanotechnology Task Force
The US Food and Drug Administration (FDA) has proposed formation of an internal FDA Nanotechnology Task Force. The new Task Force is charged with determining regulatory approaches that encourage the continued developm…
New Technology To Deal With Swelling Of Arteries
There is a completely new technology arriving to deal with aneurysm (swelling) of the arteries. This relates to implanting a PTFE covered stent in the affected artery to block off the flow of blood into the aneurysm.…
China Exports 70% of Its Medical Devices To US, Japan and Germany
The gross output value of China's medical instrument industry maintained a rapid growth since 1990s with an average annual growth rate of 12-15 per cent. China's domestic medical device manufacturing is largely domina…
European Cardiology Imaging Markets
to Benefit from Introduction of Comprehensive Packages with Enhanced Cross-departmental Workflow Integration and Multi-modality Interoperability
European IV Therapy and Enteral Nutrition Market
Increasing Incidence of Diseases Revives the European IV Therapy and Enteral Nutrition Market
European Non-Invasive Ventilators and Interfaces Market
Innovative Interfaces Key to Maintaining Revenues in European Non-Invasive Ventilators and Interfaces Market
European Patient Administration Systems Markets
Potential for Integrated Healthcare, Streamlined Workflows and Improved Administrative Efficiency Motivate Uptake of Patient Administrative Systems
Opportunities for Medical Devices in Eastern Europe
Admittance into the EU Presents New Growth Opportunities in Eastern European Medical Devices Markets
Axa Sets Up IV Fluids Facility At Roorkee
Axa Parenterals Ltd. is setting up a new sterile manufacturing facility at Roorkee in Uttaranchal for manufacturing sterile formulations. The plant will start production within two-three months.
Centre Extends Application Deadline For Import, Registration of Medical Devices to June 29
The Union ministry of health and family welfare, which came out with the guidelines for licensing of import and manufacture of medical devices with a deadline of sixty days with effect from March 1, 2006, has now post…
Govt To Spend Rs 360 Cr On Health Regulator
National Drug Authority, Modelled On USFDA, To Improve Quality Of Drugs & Clinical Trials
Health Ministry's Guidelines For Import, Manufacture of Medical Devices Effective From March 1
The Union ministry of health and family welfare has come out with the guidelines for licensing of import and manufacture of medical devices in India. The guidelines for the devices including Cardiac Stents, Drug Eluti…
Imported Non-Sterile Medical Devices Meant For Sterile Use Need Mandatory Registration
The Central Drugs Standard Control Organisation (CDSCO) has made it clear that all imported non-sterile medical devices, if meant to be used as sterile devices in the country, are subjected to mandatory registration.…
India, Germany Plan Mutual Recognition of GMP Certification
India is likely to sign an agreement with Germany on mutual recognition of Good Manufacturing Practices (GMP) certification for drug manufacturing units. A high level delegation is currently on a visit to Germany to w…
India's First Indigenous Drug Eluting Stent Receives CE Approval
Sahajanand Medical Technologies (SMT) has received CE approval (Conformité Européenne), an authorisation certificate, for qualification for the sale of Infinnium in European community and many other countries in the w…
Medical insurance is growing at a clip of 30% a year but further opening of the sector to foreign direct investment and a tariff-free regime may well provide a booster dose
Until about five year ago, PSUs were offering health insurance as part of their product portfolio under the brand name Mediclaim. With the government opening up the sector to private players, such companies as ICICI,…
MV Hospital Completes Study of Low Cost LCT Device
The Chennai based MV Hospital for Diabetes and Diabetes Research Centre has completed clinical study on a low cost Liquid Crystal Thermography (LCT) device, evolved in the research collaboration between the UK based B…
NABH Plans Quality Standards For Blood Banks, Medical Imaging Services
The National Accreditation Board for Hospital & Healthcare Providers (NABH), set up by Quality Council of India (QCI), is planning to extend its services into the accreditation of blood banks, medical imaging services…
NBI To Begin Testing of Medical Devices
Even as the government directives for the quality testing of medical devices that were recently notified as drugs are yet to materialize, the National Institute of Biologicals (NBI), Noida, has announced its intention…
"Regulation Will Help Growth of Medical Devices Sector In India"
In an interview with Nandita Vijay of Chronicle Pharmabiz, Milind Shah provides an overview of the sector and says that regulatory approval for medical devices has to be made mandatory in India. Excerpts:
Too Many New Medical Devices Leave Doctors At Sea
Last Summer, rival cardiologists in Rock Hill, South Carolina, decided to learn how to perform a lucrative new procedure, implanting a defibrillator, a device that protects against fatal heart rhythms.
UL Pitching To Be India's Authorised Certification Company For Medical Devices
The Centre has initiated a dialogue with certification organisations including UL India Private Limited, an affiliate of the US based underwriters Laboratories Inc, for appointing an authorised certification company f…
US FDA To Join PIC/S To Help In Harmonisation of GMPs
The United States Food and Drug Administration (FDA) have applied for a membership with the Pharmaceutical Inspection Cooperation Scheme (PIC/S), an international initiative to harmonise GMP standards. This is part of…
BARC Develops Alternative To Holmium For RA Therapy
The Board of Radiation and Isotope Technology (BRIT), a branch of BARC, has developed p-32, an alternative to holmium (ho-166), a radiopharmaceutical used in Radiation Synovectomy for rheumatiod arthritis. BRIT sugges…
FDA Has Always Required Hospitals To Report and Identify Adverse Events Attributable to Reprocessed Devices
FDA has always required that hospitals notify the agency when a reprocessed device was involved in adverse events associated with death or serious injury.
Fundamental differences between drugs and medical devices
The table below comparing pharmaceuticals and medical devices is aimed at emphasizing the key differences between the two types of products, which explain and justify a differentiated regulatory approach
Medical Device Reprocessing
We reproduce abstracts of a recent debate regarding use of reconditioned medical devices highlighted by "Washignton Post " under the heading , "Hospitals Save Money, But Safety Is Questioned " . The Association of Med…
The Post Does a Disservice to Patients By Instilling Panic Through Outdated or Irrelevant Examples
(Washington, D.C.) December 12, 2005 -- A year-long Washington Post investigation into the widely-used practice of reprocessing medical devices found no evidence that patients are put at an increased risk from the pra…
AMO To Launch New Ophthalmic Products In India
Advanced Medical Optics India Pvt. Ltd, the Indian arm of the US-based global ophthalmic medical device leader, Advanced Medical Optics Inc. (AMO), is expanding its market presence in India by launching new products a…
Auto Disable Syringes : Hindustan Medical Devices (HMD) Tie Ups With Pharma Multinationals
Hindustan Medical Devices (HMD), the lone domestic manufacturer of auto disable (AD) syringes, is currently on a deal signing spree with many of the pharma multinationals and some of the domestic pharma companies for…
Cardiac Stents Without Approval
Recent media reports about the use of unapproved cardiac stents on heart patients in Mumbai's JJ Hospital have brought to light the pathetic state of regulatory control on medical devices in the country. Maharashtra F…
Diagnostic Reagents And Kits : GMP Norms
The diagnostic reagents and kits manufacturers of the country will soon have to comply with a fresh set of Good Manufacturing Practices norms being finalised by the central government. The GMP norms will specify the r…
DTAB Nod On Medical Device Control On August 2
The Central Government is likely to bring in amendments to Drugs and Cosmetic Rules within three months to arm the Central Drugs Standard Control Organisation (CDSCO) to regulate the entire range of medical devices ma…
EU Model Systems For Medical Devices With BIS Fixing Approval Standards
The Central Government is likely to come out with a European Union model regulatory system for medical devices that are manufactured or marketed in the country. The highlight of the proposed system is that it will ent…
Fresenius to invest Rs 10 crore in Pune Facility
Fresenius Kabi India Pvt Ltd, a wholly owned subsidiary of Fresenius Kabi AG, Germany, is planning to increase its presence in the country in a big way. The company is in the process of upgrading its manufacturing fac…
Fresenius To Upgrade I.V. Fluid Units To European Standard
Fresenius Kabi, the European leader in infusion and nutrition therapy, which has strong market presence in emerging markets including India, would upgrade its manufacturing facilities all across the world to European…
GE Healthcare Launches High Definition Magnetic Resonance (HDMR) System In India
GE Healthcare, a division of General Electric Company, launched in India the High Definition Magnetic Resonance (HDMR) system. This breakthrough technology, which was introduced in the US in December 2004, features fi…
'Half Of The Drug Eluting Stents Used In India Lack Adequate Trial Data'
Maharashtra FDA’s recent decision to ban Drug Eluting Stents (DES) without international quality certifications stirred up a controversy in the country on the safety and quality aspects of DES used in the country. Inc…
India to outrun China in 15 years : Deutsche Bank study
Over two millions people will be participating in clinical studies in India by that time.
Mah FDA Order May Hit Domestic Stent Makers
The Maharashtra government's directive making it mandatory for manufacturers of drug eluting stents (DES) to produce USFDA and CE certification to market their products in the state will hit Indian manufacturers badly…
Medical Architecture : IIA Forming Standardised Guidelines
Just when experts are propagating the importance of accreditation and standardisation of healthcare institutes, the Indian Institute of Architects (IIA) has mooted the proposal of forming standardised guidelines in me…
Medical Packaging : DuPont P&IP to market authentication technologies
Health Ministry plans 50 testing labs in 3 years The Ministry of Health & Family Welfare has launched a major initiative to set up 50 state-of-the-art drug testing laboratories across the country within three years. W…
Medtronic To Market Endeavor DES in India
Medtronic has received CE Mark (Conformité Européenne) approval fro the commercial sale of the Endeavor DE Coronary Stent with the Rapid Exchange Delivery System. Endeavor is claimed to be the first Cobalt Alloy drug…
NGO Launches Nationwide Campaign Against Unapproved Medical Devices
Public Response Against Helplessness and Action for Redressal (PRAHAR), a Delhi based non-governmental organisation, has launched a multi-city campaign 'Making Cardiac Care Fair' against implant of 'life threatening i…
Nirma acquires Core Healthcare's IV fluids business
ARCIL a securitisation and reconstruction company acquired 60 per cent (Rs 380 crore) of CHL's total borrowing of Rs 650 crore (principal amount) about a year and a half ago. The sale is, however, subject to approval…
Nirma Close To Sealing Core Deal
Seven months after it announced its intent to acquire ailing Ahmedabad based Core Healthcare's intravenous fluids and medical devices business, FMCG major Nirma is learnt to be close to be wrapping up the deal for a l…
Paramedical & Physiotherapy Councils Bill - 2004 : Physiotherapists Find Not Acceptable
Opposing Government's initiative to club physiotherapy with paramedical council, physiotherapists across the country have demanded a "Physiotherapy Council of India".
Sterilization Plant For Medical Products Ready To Take Off
Maharashtra's first and Indai's second Gamma radiation sterilization plant in the private sector, for radiation sterilization of medical products and spices coming up at Ambernath in Thane district of Maharashtra, wil…
What are the basic matters that have to be considered while framing the rules to regulate stents?
The device should go through safety animal data, human safety trials, efficacy trials and should be submitted to the regulatory authority seeking approval. The regulatory authority must check the data and decide wheth…
Bar Code Technology For Healthcare Sector
EAN India is on an aggressive drive to educate the healthcare sector to implement EAN UCC (uniform code council) standards, which insists on use of bar codes to minimize errors in patient care. The cost of implementin…
Docs See jackpot in medical tourism
You don’t need to break a hip to come to India.
For Sector To Take Off, Legislation And Infrastructure Need To Be In Place Medical tourism can spin a dollar dream
It is tourism with a difference: healthcare or medical tourism. This is an area that Indian can have an edge in provided it is developed well. According to a McKinskey report, medical tourism can fetch up to $2bn. How…
Govt. to keep a close watch, on healthcare delivery
CONSUMERS can now hope to get better quality treatment as hospitals across the country would soon be required to adhere to some common basic quality standards for healthcare delivery. After months of rhetoric, the gov…
Indian Healthcare Federation (IHFC) To Launch Country's First Accreditation System For Healthcare Institutions
Indian Healthcare Federation (IHCF). The apex body of healthcare service providers in India, is about to launch the country's first accreditation system for healthcare institutions. IHCF is working closely with US bas…
Law For Medical Devices
Secondly, a registry of all medical devices and equipments available in the market should be prepared. There is no such list of the number and type of products with the government. A key responsibility of the new regu…
GE Medical Systems launches fastest functional imaging workstation
GE Medical Systems South Asia has introduced Xeleris, one of the industry’s fastest functional imaging workstation available in the world. Xeleris is designed to become the productivity hub of nuclear medicine and pos…
Govt plans IT standards for healthcare units
ACCESS to quality healthcare in rural areas could soon be a reality if a new government initiative fructifies. The ministry of communications and IT is in the process of developing standards for digital information ac…
Hospital Consultancy And Management : Apollo Hospitals Spreading Wings
Corporate healthcare major Apollo Hospital is steadily spreading its wings across projects management. The focus is on project consultancy and management of a hospital, promoted by other parties. Apollo Hospitals play…
Implantable device to help monitor organ function
Health experts are of the opinion that tiny implantable devices may be used to track organ function in the near future.
Indian Healthcare Industry: Rising change In Attitude By Middle Class
ARISING middle in come group and a change in attitude to-wards healthcare is driving the growth in the Indian healthcare industry.
Ischemia Albumin Blood (IMA) Test : USFDA Clearance To Market The Albumin Cobalt Binding (ACB) Test
Pharmacopoeia Commission to be set THE long-awaited Indian Pharmacopoeia Commission (IPC) is likely to come into being in April. The health ministry has moved a Cabinet note proposing setting up the IPC with an initia…
Medical Tourism : Hospitals, Maharastra State Govt Team Up To Lure Medical Tourists
Dengue Detection Kit : CHPL tie-up with Panbio, a world leader in dengue detection kits CHPL has a tie-up with Panbio, a world leader in dengue detection kits, and is the first company in India to make available the k…
Stents : Quality Control Is A Must (A Report By the Forum For Medical Ethics )
A forum for Medical Ethics study indicates that a frighteningly large number of doctors makes their prescriptions based on kickbacks rather than quality. The government, meanwhile, does not even pretend to regulate th…
UL India offers safety certification for equipment vendors
. UL India, an affiliate of Underwriters Laboratories Inc. (UL Inc., USA) is confident that, by the end of this year, at least 50 medical equipment vendors would utilize its services in certification for product safet…
Unicondylar Arthroplasty : A New Technique of Surgery For Knee Joint
The joint replacement surgery unit (JRSU) at the Civil Hospital, Ahmedabad, India has introduced Unicondylar Arthroplasty – a new technique of surgery – which requires changing of only a part of knee joint for early o…
Industry News Page 2 of 2
ENGINEERING and construction conglomerate, Larsen & Toubro (L&T) has decided to tap the global medical equipment market in a big way. This would be achieved mainly through offering contract manufacturing to foreign co…
TTK Healthcare plans to export artificial heart valves
Chennai-based TTK Healthcare Ltd, part of the diversified TTK Group, buoyed by the encouraging performance of TTK-Chitra Heart Valve Prosthesis in the domestic market, is now firming up plans to export these heart val…
Industry News Page 1 of 2
India needs to step up its efforts in the field of healthcare by improving the state of its medical equipment, instruments, devices and software, according to the Confederation of Indian Industry. The summit, with Ger…
Industry News Page 2 of 2
The Mohali-based Adonis Medical Equipments Pvt Ltd plans to launch its new product C-Arm by the end of the year. It aims to bring different types of products with conventional technology (economical) and high frequenc…
Industry News Page 2 of 2
Innoval Medical India, a Chennai-based blood bag manufacturer, is planning to come out with its Initial Public Offer (IPO) shortly. The company has proposed to enter into production of intravenous and blood transfusio…
Industry News Page 2 of 2
Apollo Hospitals group is forming a joint venture with Parkway Hospitals group of Singapore to set up psuper-speciality hospitals outside India and Singapore. Apollo Hospitals group chairman Prathap C Reddy said that…
About Humanitarian Use Medical Devices (HUDs)
On June 26, 1996, FDA issued a final rule to carry out provisions of the Safe Medical Devices Act of 1990 regarding humanitarian use devices (HUDs). An HUD is a device that is intended to benefit patients by treating…