Indian Medical Devices Industry Baffled by Adhoc Pick & Choose Regulations
New Delhi: Mr. Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) said “We are baffled to see above notification same evening in conflict with our discussion at the first meeting held by the Central Drugs Standard Control Organization regarding the “road map” for regulating the sale and manufacture of all medical devices in India in a phased step by step approach. We wonder what’s the logic and rationale behind this random pick and choose approach? ”
Voicing Industry’s concern Mr. Nath said – Until 2020 is too short, at least 5 years Transition period is needed to build infrastructure and capability and capacity of Regulators, Auditors , Testing facilities and also of Manufactures or you will have a case of non enforced/ non enforceable regulations and inadvertently building market access barriers to home grown manufacturers who will be struggling to get licensed and competing with USFDA qualified importers.
Similar opinion was given by Mr Anil Jauhri, CEO of QCI – NABCB who had given a presentation to regulate all medical devices at the Department of Commerce Conclave on Standards at Mumbai last week. “Device by Device regulations will not work. “He has suggested following a hierarchy of standards to regulate categories of devices – e.g., initially using horizontal Risk Management & Quality Management Standards common to all products followed by semi horizontal standards that are applicable on specific categories of devices eg Sterility for sterile products, electrical safety for electronic devices and biocompatibility for implants etc.”
Another expert , Dr. Jitendar Sharma, Mg. Director of Andhra Medtech Zone opined , “Better than item by item regulations it’s prudent to regulate devices by category in a phased manner. It’s better to regulate by category eg: non ionising diagnostic equipment, ionising diagnostic equipment, all medical electronics with power extrusion , all medical electronic equipment with / without motors , all IVD consumables & all IVD Disposables , all medical disposables , all medical consumables etc.with listed examples with common validation and testing needs”.
“It’s better to initially regulate categories by risk classification eg high risk devices first or where devices are being manufactured already in India to support manufacturers with Regulatory certification for enabling their credibility or Indian manufacturers need to seek 3rd country regulatory approval to sell and are challenged to access our own home market and items where we have less manufacturing capabilities could be considered last of all as expertise to test, audit, qualify may not be there immediately as acknowledged by DCGi in meeting and country needs time to develop regulatory capacity and capability, said Nath. He explained ,
- Current state: Regulated Product list is a bunch of products and new products are envisioned to be added over a period of time
- Similar category of products require same validation infrastructure, which needs to be added in the country simultaneous with extension of products into regulatory main-stream
- Regulatory Devices list needs to be EXPANDED as per PRODUCT SEGMENT and NOT products: The following is proposed as extension of regulated product basket:
- Electronics without motor – 2 years , eg 2020 (needing EMI-EMC testing facilities)
- Electronics with motor – 3 years , eg 2021 (needing electrical safety testing)
iii. In-vitro diagnostics & consumables- 3-4 years eg2022(needing ETO, Gamma)
- Biomaterials & implants – 4-5 years Eg 2023 (needing accelerated aging, Bio-material centre) v. Patient Aids: 5 years 2024(needing mechanical testing, 5 g/10g testing)
- MDR should cover ionising and non ionising Radiation products but in categories and not as products and should give 4-5 years time for implementation, so 2024
- Regarding Regulations of implants as a category. This is category wise which is ok but order is not clear if it covers all 3 sub categories of implants viz , transient( few hours) , short term ( few days ) and long term ( over 30days) or only long term . We have sought clarification .
- Secondly, in EU /ISO , ISO stds provides upto 3 years Transition period and EU / Singapore etc it’s 5 years for major amendments to regulations where regulations are already existing and robust. Item by item coverage
Urging for CDSCO’s immediate support to amend the MoH&FW notification, Dr.Jitender Sharma said “The notification issued is a faulty notification made without a draft notification having been discussed or consulted with all impacted stakeholders and this needs amending ASAP or it will kill impetus being created of make in India of high end equipment being initiated in AMTZ. You can’t regulate a few 100 Dialysis equipment and not regulate lacs of dialysers at all”