Medical device licencing requests issued till September will be valid for 6 months: CDSCO
New Delhi: With an aim to not disrupt the medical device business continuity due to the implementation of licensing regime, the Government of India, the Director-General of Health Services, the Central Drug Standard Control Organization (CDSCO) has decided that, in case, if an existing importer/manufacturer who is already importing /manufacturing any of Class A or Class B Medical Devices,...
New Delhi: With an aim to not disrupt the medical device business continuity due to the implementation of licensing regime, the Government of India, the Director-General of Health Services, the Central Drug Standard Control Organization (CDSCO) has decided that, in case, if an existing importer/manufacturer who is already importing /manufacturing any of Class A or Class B Medical Devices, has submitted application to Central Licensing Authority or State Licensing Authority on or before 30.09.2022, the said application shall be deemed valid.
Furthermore, it is stated that the above mentioned importer/manufacturer can continue to import /manufacture the said device(s) up to 6 months from the date of issue of this order or till the time, the Central Licensing Authority or State Licensing Authority takes a decision on the said application, whichever is earlier.
This came in line with the representations from various Associations and Stakeholders which have been received by this office, requesting that the business continuity should not be disrupted due to the implementation of licensing regime w.e.f. 01.10.2022 for Class A & B medical devices.
The Ministry of Health and Family Welfare (MoHFW) has published a notification, S.O. 648 (E), dated February 11, 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 April 1, 2020.
It is noted that stakeholders and various associations requested the committee not to discontinue their businesses due to the implementation of the licensing regime w.e.f. October 1, 2022 for Class A and B medical devices.
Earlier Medical Dialogues Team had reported about the entering licensing regime of Class A and Class B non-notified medical devices from October 1st 2022. It also mentioned about CDSCO's online portal to apply for the manufacturing license for Class A and Class B medical devices.
In view of the above, it has been decided that, in case, if an existing importer/manufacturer is already importing /manufacturing any of Class A or Class B Medical Devices, has submitted application to Central Licensing Authority or State Licensing Authority on or before 30.09.2022, as the case may be, for grant of import /manufacturing license in respect of the said device(s) under the provisions of MDR, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import /manufacture the said device(s) up to 6 months from the date of issue of this order or till the time, the Central Licensing Authority or State Licensing Authority, as the case may be, takes a decision on the said application, whichever is earlier.
To view the official notice, click the link below:
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