Govt Extends Deadline to Class C & D Medical Device Manufacturers Facing Licence Approval Delays

The Indian government has announced a six-month extension for existing manufacturers and importers of high-risk medical devices who have applied for licences. 

This decision significantly relieves the healthcare industry, particularly those dealing with 'class C' and 'class D' medical devices.

The Central Drugs Standard Control Organisation (CDSCO) had initially set October 1 as the deadline for bringing 'class C' and 'class D' medical devices under regulatory control, part of the ongoing efforts to ensure quality and safety. 

Manufacturers had diligently submitted applications to obtain licences, but the government faced challenges processing them within the stipulated time frame.

In an official circular dated October 12, the CDSCO stated, "It has been decided that, in case an existing importer/manufacturer who is already importing/manufacturing any of the above said Class C or Class D Medical Devices, and has submitted an application to the Central Licensing Authority for the grant of import/manufacturing license, the said application shall be deemed valid." 

Consequently, these manufacturers can continue to import and manufacture the specified devices for up to six months from the date of this order or until the Central Licensing Authority decides on their applications, whichever comes earlier.

The newly regulated medical devices falling under these categories include critical equipment such as ventilators, imaging equipment, oxygen therapy devices, nebulisers, x-ray equipment, surgical robots, and oncology treatment linear accelerators. 

As per the updated regulation, these devices cannot be sold from October 1 without a valid manufacturing licence. Many manufacturers applied for licences in July, expressing concerns about the delayed audits essential for licence issuance.

Rajiv Nath, forum coordinator of the Association of Indian Medical Devices Industry (AiMeD), expressed relief at the government's decision. He said, "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 license but could not get it due to challenging application review and processing."

Earlier reports highlighted the government's consideration of allowing high-risk medical device manufacturers to continue production for a limited period due to delays in issuing new licenses necessary for sustaining production. 

Around 200 medical device manufacturers had ceased operations due to these delays, raising concerns within the industry and on social media platforms about the importance of swiftly resolving this issue for the industry and public health.