F. No. 29/Misc/03/2023-DC (344) Central Drugs Standard Control Organisation Government of India Ministry of Health and Family Welfare oi 2k ie 2 2 2k 2

FDA Bhawan, New Delhi Dated _ 12 OCT 2073 |

CIRCULAR

Subject: Regulation of all Class C & D Medical Devices under Licensing regime, w.e.f 01.10.2023, as per G.S.R. 102(E) dt 11.02.2020 - Regarding.

The Ministry of Health & Family Welfare (MoHFW) has published 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.

In order to regulate all the medical devices, MoH W has published G.S.R. 102 (E) dated 11.02.2020 for regulation of such devices in phase wise manner. As per the said notification the Class C & D medical devices will be under licensing regime from 01.10.2023. In the meantime, representations from various Associations and Stakeholders 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. 01.10.2023 for Class C & D medical devices. a

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In view of the above, 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 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, — is earlier.

(Dr.DrugsRajeevControllerSingh Raghuvanshi)General (I) To All Stakeholders/Associations. ,

Copy to: 1. All Zonal/Sub-Zonal offices of CDSCO

2. All Port offices.

3. CDSCO- IT Cell for publication on website