Industry Seeks Extension in Medical Devices Regulation

Medical device manufacturers in India have formally requested a six-month extension from the Union Ministry of Health and Family Welfare to comply with quality licensing rules for high-risk medical devices. The products, falling under Class C and Class D categories as per the 2020 amended Drugs and Cosmetics Act, encompass items like ventilators, imaging equipment, oxygen therapy equipment, nebulizers, X-ray equipment, surgical robots, and oncology treatment linear accelerators. The industry had an initial deadline of September 30, 2023, to adhere to the Medical Devices (Amendment) Rules, 2020, requiring licenses for high-risk category products by October 1, 2023.

The Association of Indian Medical Device Industry (AiMED) has cited procedural delays by regulators as a key reason for the extension request, specifically pointing to resource constraints at the Central Drugs Standard Control Organization (CDSCO) in conducting timely inspections and issuing manufacturing licenses. AiMED’s Forum Coordinator, Rajiv Nath, expressed concerns about potential supply chain disruptions for Indian-made medical devices if the deadline is not extended.

The letter dated September 25 outlines that over 1,000 manufacturing licenses are still in process for 200-300 manufacturers of high-end, high-risk medical devices. This indicates a potential delay in inspections by the CDSCO despite manufacturers being ready. The industry’s resistance to regulations has been ongoing, and the 2020 amendment met with opposition. India’s medical devices market imports a significant portion of products from foreign sources, and regulatory compliance is a crucial aspect of ensuring patient safety and access to quality products at affordable prices.