CDSCO gives 6-month extension to medical device manufacturers for imports

Under the new regulation, medical devices under' class C' and 'class D' cannot be sold without a manufacturing licence after October 1

The Indian government has granted a six-month extension to existing manufacturers and importers of high-risk medical devices if they have already applied for licences.

The Central Drugs Standard Control Organisation (CDSCO) had set a deadline of October 1 for bringing "class C" and "class D" medical devices, including ventilators, imaging equipment, and surgical robots, under the new regulation. The new regulation to govern all medical devices in India mandates that medical devices under these categories cannot be sold without a manufacturing licence after the deadline. Following the announcement, many manufacturers raised issues regarding the deadline as they awaited licenses, which they had applied for months in advance.

The Association of Indian Medical Device Industry (AiMED), an organisation representing domestic medical device makers, also sought an extension of this deadline. In a letter to Health Minister Mansukh Mandaviya, dated September 25, AiMED cited concerns about the resource constraints of the CDSCO in conducting timely inspections and issuing manufacturing licences before the stipulated deadline.

The government, in a circular dated October 12, has decided to allow manufacturers who have applied for licenses to continue importing and manufacturing these devices for an additional six months from the date of the government's order or until the Central Licensing Authority makes a decision on their application, whichever comes first. This decision significantly relieves the medical device industry, allowing them to continue operations while awaiting license approvals.

The CDSCO circular read, "It has been decided that, in case, if an existing importer/ manufacturer who is already importing/ manufacturing any of the above said Class C or Class D Medical Devices, has submitted application to Central Licensing Authority, for grant of import /manufacturing licence in respect of the said devices) under the provisions of Medical Devices Rules, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import/manufacture the said device(s) up to six months from the date of issue of this order or till the time, the Central Licensing Authority, takes a decision on the said application, whichever is earlier."

Following the extensions, Rajiv Nath, forum coordinator at AiMeD told The Economics Times, "At AiMeD we are relieved with this circular by the government giving a six-month reprieve to those manufacturers who had timely applied for a manufacturing licence but could not get it due to challenging application review and processing."