Dated:- 12.10.2023

F. No. 29/Misc/03/2023-DC (344)

Central Drugs Standard Control Organisation

Government of India
Ministry of Health and Family Welfare

Circular

Sub: Clarification on the 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.

In continuation to this office Circular vide No.29/Misc/03/2023-DC(344) dated 12.10.2023 on the 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.
In this connection, it is to clarify that the said circular is applicable only to the manufacturers/importers who have already filed the application to Central Licensing Authority on or before 30th September 2023.

Dated:- 12.10.2023

F. No. 29/Misc/03/2023-DC (344)

Central Drugs Standard Control Organisation

Government of India
Ministry of Health and Family Welfare

Circular

Sub: 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 (MoIIFW) has published notification vide S.O. 648 (F) 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, MoIIFW 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.
In view of the above, it has been decided that, in case, i f 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, which .r is earlier.

Dated:- 11.10.2023

GOVERNMENT OF INDIA

MINISTRY OF HEALTH & FAMILY WELFARE
DIRECTORATE GENERAL OF HEALTH SERVICES
CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (COSCO)
OFFICE OF THE ASSISTANT DRUGS CONTROLLER (INDIA)
ROOM No.4-A, Import-||| Building , IGI Cargo Complex,
New Delhi-110037

Circular / Notice

Sub: Submission of documents / files in online mode for imported consignment at the O/o ADC (I), IGI, Airport – regarding.

With reference to order dated 10. 10.2023 received from CDSCO, HQ, New Delhi on the subject cited above. It .is noted that applicants are submitting the applications/documents in physical file for release of imported consignment to the O/o ADC(I), IGI Airport, New Delhi.
In this regard, you are requested to submit the applications/documents for obtaining NOC for imported consignment by email only (i.e. adcigia@cdsco.nic.in) to the O/o ADC(I). No Physical files will be accepted from 16.10.2023 (Monday) for issuing of NOC.