DCGI grants 6 month license compliance extension to medical device manufacturers

Back in February 2020, the Indian government had set a 42-month deadline, culminating on October 1, 2023, for all manufacturers of Class C and D medical devices to obtain licenses

In a recent announcement, the Drug Controller General of India (DCGI) has provided a six-month extension to manufacturers of Class C and D medical devices who had submitted their licensing applications before the deadline of September 30, 2023. This extension allows these medical device manufacturers to continue their production for the next six months or until the licensing authority reaches a decision on their application, whichever comes first, as stated in the DCGI’s letter dated October 12, 2023.

Back in February 2020, the Indian government had set a 42-month deadline, culminating on October 1, 2023, for all manufacturers of Class C and D medical devices to obtain licenses. However, due to representations from various industry associations and stakeholders, the Central Drugs Standard Control Organization (CDSCO) received requests to prevent any disruption in business continuity resulting from the implementation of the new licensing regulations starting on October 1.

“In view of the above, it has been decided that, in ease, if an existing importer/manufacturer who is already importing/manufacturing any of the above said Class C or Class D Medical Devices, has submitted an application to Central Licensing Authority, for grant of import/manufacturing licence in respect of the said device(s) 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,” the DCGI’s letter said.

This extension comes as a response to the concerns raised by medical device manufacturers who were facing uncertainty regarding their pending license applications, with approximately 200 manufacturers failing to receive their licenses before the October 1, 2023 deadline, despite submitting their applications on time. This situation had disrupted the production and distribution of medical devices, as they could not legally proceed without the necessary licenses.

Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AIMED) said, “At (AIMED), we are relieved with this written circular by the government giving a 6 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 – we also hope that the Government brings on board individual experts or organisational expertise available with Quality Management System Certification Bodies accredited by Quality Council of India for the voluntary Quality Assurance Indian Certification of Medical Devices (ICMED) scheme as manpower resources like its being done for the lower risk Class A & B medical Devices. This order helps allay the nervous anxiety of these unlicensed manufacturers and continuity of business is assured as well as no disruption of access to needy medical users and consumers- we appreciate the responsiveness of the DCGI & MoH&FW.”