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New Draft Schedule M-III For Indian Medical Device Industry

DCGI has posted the draft Medical Device Regulation, Schedule M-III at their website . http://cdsco.nic.in/Medical_Devices_Guidelines.pdf

The proposals have been issued in the form of draft guidelines. They would modify the Drugs & Cosmetics Act’s Schedule M III, which deals with requirements for manufacturing, importing and selling medical devices in India. The draft Schedule M-III has been posted on the CDSCO’s website for stakeholders to submit feedback; no deadline for accepting comments is given.

The Association of Indian Medical Device Industry (AIMED) has welcomed the proposals. “This would put an end to the problems being faced by the local medtech companies at present as our products [barring a few specifically classified as devices] are regulated as drugs,” Rajiv Nath of AIMED said.

The association plans to submit feedback once it has reviewed the proposals in full.

Guidelines For The Regulators For Assessment Of A Medical Device Manufacturing Organization

A. To define the guidelines to be followed by the representative of regulatory body while evaluating an application for registration or granting manufacturing license and for auditing a medical device manufacturer.

The scope of assessment will mainly depend on the risk classification of the medical device being manufactured.

The following points are to be assessed:

1. A quality management system (ISO 13485 / IS 15579) for ensuring GMP (Good Manufacturing Practices) should be in place to minimize human mistakes, to track raw material used and to track devices, to take suitable action if a malfunction is reported. Job responsibility must be defined to fix the responsibility of failure.

2. Suitability of raw material used should be demonstrated.

3. Suitability of packaging should be demonstrated.

4. If sterilized, the sterilization system must be validated.

5. Design validation in cases of class C & D products: If a design is already existing no design validation may be required, only demonstration of equivalence may suffice. In cases where the design is new or substantially modified, design validation is required by way of suitable clinical evaluation.

The level of regulatory controls for different classes of product would be followed as:

No. Risk Classification Product Requirement
1 A Catheter
– Invasive in
body orifice or
stoma (not surgically)
– Transient use
• Manufacturer shall register with the CLAA.
• Manufacturing license not required.
2 B Catheter
– Surgically invasive
– Transient use

I. V. Cannula
– Surgically invasive
– Short term use

Scalp Vein Sets
– Surgically invasive
– Short term use

• Manufacturer’s quality management system to be assessed and certified by a notified body.
• The manufacturer will be registered with the CLAA on the basis of certificate from notified body.
• Manufacturing license not required.
3 C Intra Ocular Lenses
- Surgically invasive
- Long term use
- Implantable devices

Bone Cements
- Surgically invasive
- Long term use

Orthopaedic Implants
- Surgically invasive
- Long term use
- Implantable devices

Internal Prosthetic replacements
- Surgically invasive long term use implantable devices)

• Certification by a notified body is required with regard to the quality management system (ISO 13485 / IS 15579) raw material used, packaging used, sterilization validation. Certification of design if the design is already in use by others and manufacture of the device.
• CLAA will register the manufacturer on the basis of Notified body's assessment, if the design is already in use by others.
• Manufacturer required to apply for manufacturing license to CLAA with supportive documents with respect to safety and effectiveness of device.
• The manufacturing license will be issued by CLAA on the basis of above documents and certificate issued by the notified body.
4 D Catheter
- Short term use
- Surgically invasive
- Direct contact with central circulatory system

Cardiac Stents
- Surgically invasive
- Long term use
- Direct contact with central circulatory system

Drug Eluting Stents
- Surgically invasive
- Long term use
- Direct contact with central circulatory system

Heart Valves
- Surgically invasive
- Long term use
- Direct contact with Heart

• Certification by a notified body is required with regard to the quality management (ISO 13485) raw material used, packaging used, sterilization validation & manufacture of the device.
• Manufacturer required to apply for registration to CLAA with supportive documents with respect to safety and effectiveness of device.
• Manufacturer facility may be audited by a team of auditor from notified body (an interim team may be formed by CLAA) to assess the compliance with Quality Management system standards ISO 13485/IS 15579 (if required representative from state & CLAA can accompany the team as observers).
• Manufacturing license will be issued by CLAA based on the recommendation of the auditors.

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