Class A & B Devices have been regulated since April 1 and manufacturers who were registered but not Licensed on April 1 were allowed to continue manufacturing and selling while the state and central government regulators sought compliance and audit certification etc . Similar written clarity is awaited for the High-Risk medical devices

Rajiv Nath ,Forum Coordinator ,AiMED said , Class C & D medical devices had to come into regulation today and we had sought an extension as per the letter above as CDSCO doesn’t have the resources to timely issue a Manufacturing License to all applicants.

Today the competent manufacturers should have got a Liscense issued but as not done legally sales can’t be done in the absence of a manufacturing License so AiMeDs members have been contacting me to seek clarity – legally from today sales need to stop and no billing is possible without manufacturing License, is my advice to them.

We contacted CDSCO and they informed us that they are awaiting the formal note from MoH&FW so that they can then give clarity to us whether sales can be done by registered manufacturers in the absence of a License till a license can be issued to manufacturers- DCGI is not in the office and until he’s back no manufacturing License can be signed off. AiMeD has written to Minister of Health who is also Minister of Pharmaceuticals, Chemical & Fertilizers, we seek your help and kind intervention to ensure no disruption of the supply chain and to give the anxious manufacturers and consumers clear communication.

A letter is written by the Association of Medical Device Industry an apex body of Indian Medical device manufacturers on September 25 to Health Minister Mansukh Mandaviya, , sought additional time, citing concerns about the resource constraints of the Central Drugs Standard Control Organisation (CDSCO) in conducting timely inspections and issuing manufacturing licenses before the stipulated deadline of October 1.

Most of the manufacturers are not licensed and many applications are pending for approval at CDSCO. and they have reached out to AiMED to be the voice of the industry and expressed their concern.

It’s important to note that the regulatory landscape for medical devices in India may evolve, and there may be changes or updates to the licensing process after September 2021. For the most current and detailed information, manufacturers and stakeholders are advised to refer to the official guidelines and notifications from the CDSCO and other relevant authorities.