This circular addresses the implementation of a licensing regime for Class A & B medical devices, as mandated by G.S.R. 102(E) dated 11.02.2020, which was scheduled to take effect on October 1, 2022.
It provides a grace period for existing importers/manufacturers of Class A and B medical devices who have already applied for licenses before September 30, 2022.
Key Changes
The original notification G.S.R. 102(E) dated 11.02.2020, mandated that Class A & B medical devices would be under a licensing regime starting October 1, 2022.
Due to representations from stakeholders, a provision is made for existing importers/manufacturers.
If an importer/manufacturer submitted a license application to the Central Licensing Authority or State Licensing Authority on or before September 30, 2022, they can continue to import/manufacture the devices.
This continuation is allowed for up to 6 months from the date of the circular (September 30, 2022) or until the licensing authority makes a decision on the application, whichever is earlier.
Impact Analysis
Manufacturers/Importers of Class A & B Medical Devices
Action Item: Closely monitor the status of license applications and respond promptly to any requests for information from the Central Licensing Authority or State Licensing Authority.
Central Licensing Authority/State Licensing Authority
Action Item: Communicate clearly with applicants regarding the status of their applications and any additional information required.
Associations and Stakeholders
Action Item: Communicate the details of this circular to their members, emphasizing the importance of having submitted license applications by the deadline.
Consumers/Patients
Potential Risk: Possible quality concerns if manufacturers continue operations without proper licensing. However, the licensing authorities are expected to mitigate this risk through due diligence.
Key Entities Referenced
Ministry of Health & Family Welfare (MoHFW): The government ministry responsible for health policy and regulations, which published the notifications S.O. 648 (E) and G.S.R. 102 (E).
Central Drugs Standard Control Organisation (CDSCO): The national regulatory body for pharmaceuticals and medical devices in India, responsible for implementing the licensing regime.
Central Licensing Authority: The authority responsible for granting import/manufacturing licenses at the central level.
State Licensing Authority: The authority responsible for granting manufacturing licenses at the state level.
Drugs and Cosmetics Act, 1940: The primary legislation governing the regulation of drugs and cosmetics in India. Section 3(b)(iv) defines medical devices covered under the act.
Medical Devices Rules, 2017 (MDR, 2017): The rules governing the regulation of medical devices in India, including the licensing requirements.
G.S.R. 102(E) dated 11.02.2020: The gazette notification that originally mandated the licensing regime for Class A & B medical devices from 01.10.2022.
S.O. 648 (E) dated 11.02.2020: Notification 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.
File No.29/Misc/03/2022-DC(257)
F. No. 29/Misc/03/2022-DC (257)
Central Drugs Standard Control Organisation
Government of India
Ministry of Health and Family Welfare
*******
FDA Bhawan, New Delhi
Dated the 30th September, 2022
CIRCULAR
Subject: Regulation of all Class A & B Medical Devices under Licensing regime, w.e.f
01.10.2022, 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, MoHFW 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 A & B medical devices will be under licensing regime from 01.10.2022.
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. 01.10.2022 for Class A & B medical devices.
In view of the above, it has been 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, as
the case may be, for grant of import /manufacturing licence 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.
(Dr. V. G. Somani)
Drugs Controller General (I)
To
All Stakeholders/Associations.
Copy to:
1. All State Drugs Controllers.
2. All Zonal/Sub-Zonal offices of CDSCO
3. All Port offices.