Medical device manufacturers have formally requested a six-month extension to comply with mandatory licensing for Class C and D medical devices, as mandated by the Drugs and Cosmetics Act. The Association of Indian Medical Device Industry (AiMED), representing domestic medical device makers, sent a letter dated September 25 to Health Minister Mansukh Mandaviya, outlining their concerns. They cited resource constraints within the Central Drugs Standard Control Organisation (CDSCO), hindering timely inspections and issuance of manufacturing licenses before the October 1 deadline.

In the letter, Rajiv Nath, the forum coordinator of AiMED, explained the need for an extension, expressing worries that CDSCO's limited resources might lead to supply chain disruptions for numerous Indian-made medical devices. According to the New Medical Devices Regulations, 2020, manufacturers were given a 42-month transition period, starting from April 1, 2020, to complete licensing for non-notified Class C and D medical devices.

An industry expert highlighted the need for clarity regarding high-risk medical devices. He estimated that around 1,000 manufacturing licenses are in process for 200-300 manufacturers producing these high-end medical devices. Starting from October 1, all Class C and D devices are to be subject to licensing requirements under non-regulatory medical devices.

Without proper licenses, legal sales cannot proceed, and manufacturers must halt billing until they obtain a manufacturing license. Manufacturers have sought clarification from CDSCO and the Union health ministry regarding whether registered manufacturers can conduct sales in the absence of a license. The medical devices falling under Class C and D categories include critical equipment such as defibrillators, ventilators, imaging devices, oxygen therapy equipment, and nebulizers.

Source: Business Standard