DCGI Gives Six-month Extension To Medical Device Makers For Licensing Compliance
On Thursday, the Drug Controller General Of India (DCGI) in its latest letter gave an extension of six months to the medical device manufacturers of Class C and D devices who have filed their licensing application before 30 September 2023. Now the medical device manufacturers can continue to manufacture for the next six months or till the time the licensing authority takes a decision on their application whichever is earlier, the DCGI letter dater 12 October 2023 said.
DCGI in the letter said that the government had notified manufacturers in February 2020 giving a deadline of 42 months ending on October 01 2023 for all medical device makers making Class C and D products.
The letter further said that representations from various associations and stakeholders were received by the Central Drugs Standard Control Organisation (CDSCO) requesting that the business continuity should not be disrupted due to the implementation of the licensing regime from 01 October.
"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.
The extension comes against the backdrop of medical device makers who were voicing their concerns about pending applications at the regulator's doorstep. Reportedly an estimated 200 manufacturers did not receive their licenses before the deadline of 01 October 2023 even after submitting the applications before the deadline. This disrupted the manufacturing of device makers as they could no longer bill their devices without a legal license.
