A notification was issued recently by CDSCO. Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) said, “We are baffled to see notification same evening in conflict with our discussion at the first meeting held by the Central Drugs Standard Control Organisation 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 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.”
Similar opinion was given by 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 and quality management standards common to all products followed by semi horizontal standards that are applicable on specific categories of devices.
Another expert, Dr. Jitendar Sharma, MD, 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 e.g. 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”. Ì