CDSCO Accepts Class C and D Medical Device Applications for license Valid for 6 Months
New Delhi: With an aim to avoid disrupting business continuity due to the implementation of the licensing regime with effect from 01.10.2023 for Class C and D medical devices, the Central Drugs Standard Control Organisation (CDSCO) has decided to accept applications for license submitted by manufacturers or importers of Class C and D medical devices as deemed valid for up to six months.
This was in response to the submissions the office received from a number of Associations and stakeholders requesting that the licensing scheme for Class C and D medical devices not interfere with business continuity starting on October 1, 2023.
A phased approach to the regulation of medical devices was previously outlined in G.S.R. 102 (E), dated 11.02.2020, which was published by MOHFW. The aforementioned notification
Based on the level of risk they pose, Class A and B devices are categorized as low-risk and moderate-risk devices, respectively, whereas Class C and D devices are classified as high-risk and extremely high-risk devices, respectively.
The Ministry of Health and Family Welfare (MOHFW) published a notification vide S.O. 648 (E) dated 11.02.2020 specifying all medical devices under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940, which is effective from 01.04 2020.
The Ministry of Health and Family Welfare (MOHFW) published G.S.R. 102 (E) dated 11.02.2020, introducing a phased regulation for all medical devices, with Class C and D devices transitioning to a licensing regime starting from 01.10.2023.
Meanwhile, this office has received requests from different associations and stakeholders, who have expressed concerns about the potential disruption to business continuity resulting from the implementation of the licensing regime for Class C and D medical devices starting from 01.10.2023.
Considering the foregoing, the notice said,
"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 an application to Central Licensing Authority, for a grant of import /manufacturing license 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, which is earlier."
