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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 useI. 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 devicesBone 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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