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AMTZ Partners With GMDN Agency For
Identification Of Medical Devices
Attracting attention of medical device fraternity across the
world, the Andhra Pradesh MedTech Zone (AMTZ) recently joined the Global Medical
Device Nomenclature
(GMDN) Agency as partners.
The GMDN Agency is responsible for the Global Medical Device
Nomenclature used for identification of medical devices. Formed in 1991, medical
device experts from around the world (regulators, healthcare providers and
manufacturers) have compiled the GMDN to facilitate taxonomy on medical devices.
GMDN is a list of generic names used to identify all medical
device products including those used in the diagnosis, prevention, monitoring,
treatment or alleviation of disease or injury in humans.
A standardized and unambiguous system for naming and coding
medical devices is critical in an environment increasingly dependent on
electronic data records for sharing and storing patient information. GMDN is
recommended by the International Medical Device Regulators Forum (IMDRF) and is
now used by over 70 national medical device regulators to support their
activity.
With AMTZ as a Consulting Organisation to GMDN, it will be a
great value-addition to all the manufacturers at AMTZ. GMDN association with
AMTZ will come as an enabler of export and global market expansion potential.
In order to facilitate regulation of medical device with
classification system as stipulated in medical device rules, 2017 among other
aspects like sale and distribution, import and labeling of medical devices,
Union Health Ministry has permitted AMTZ to host a dedicated help desk for
understanding and smooth implementation of Medical Device Rules, 2017.
The help desk would also facilitate information on following
changes of medical devices rules to manufacturers like licensing authorities and
functions of notified body, manufacture of medical devices for sale and
distribution, import and labeling of medical devices, clinical investigation of
medical device and clinical performance evaluation of IVD’s, import or
manufacture medical device which does not have predicative device, duties of
medical device officer, medical device testing officer and notified body,
registration of laboratory for carrying out test for evaluation.
Taking forward its mandate of Make in India, Government of
Andhra Pradesh last year established country’s first medical technology
manufacturing park, AMTZ in Vishakhapatnam. N Chandrababu Naidu, chief minister
of Andhra Pradesh laid the foundation stone of AMTZ.
Since then, AMTZ has received good response in terms of
commencing of booking of plots and its active participation at Indian Medical
Device Conference – 2017, one of the largest events for the Indian
pharmaceutical market.
(Ref :
http://www.pharmabiz.com/NewsDetails.aspx?aid=102330&sid=1)
Gujarat FDCA To Tie Up With NIPER
Ahmedabad To Train Inspectors For Detecting SAE Of Medical Devices
Gujarat FDCA is planning to collaborate with National
Institute for Pharmaceutical Education and Research (NIPER) Ahmedabad to equip
officers on detection of serious adverse events (SAE) caused by the use of
medical devices to ensure patient safety.
This will be a major boost to the government’s
materiovigilance programme of India launched two years ago. Materiovigilance
Programme of India was launched by the Union Health Ministry on July 6, 2015 at
Indian Pharmacopoeia Commission (IPC), Ghaziabad.
Ministry has already sanctioned an amount of Rs. 15 crore
towards setting up a dedicated medical device testing lab at Vadodara some time
back.
Recommended and promoted by the Union commerce ministry, the
country’s flagship project will be developed in partnership with Union health
ministry with technical support from Healthcare Technology Division of National
Health Systems Resource Centre (NHSRC), a technical support institution under
the Union health ministry.
Setting up of a dedicated medical device testing lab in the
country would be a boon for the Indian manufacturers to help adhere to
compliance towards patient safety as the country today lacks in registering and
thereby reporting adverse events due to faulty medical devices at the point of
care.
Till date, products are usually sent to foreign countries for
testing due to lack of a reliable and advanced medical device testing facility
in the country. Though the government plans to set up two medical device testing
labs in the country at Vadodara in Gujarat and another at Noida subject to
getting approvals, medical device testing lab in Gujarat would be the first and
the only dedicated biomaterials and implants testing lab in the country. The lab
at Noida will be set up primarily to test electrical and electronic medical
devices in the country.
Gujarat FDCA pursued the matter of setting up the medical
device testing lab based on an Engineering Export Promotion Council (EEPC) Meet
at Ahmedabad one and a half years ago which raised the demand for setting up a
dedicated medical device testing lab to ensure quality assurance of medical
devices manufactured in the country.
(Ref :
http://www.pharmabiz.com/NewsDetails.aspx?aid=102360&sid=1)
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