**Summary:**
This notification, issued by the Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare, Government of India, addresses the registration and labeling requirements for medical devices. It references notifications S.O. 648(E) and G.S.R. 102(E), both dated February 11, 2020, which brought all medical devices under the Drugs and Cosmetics Act, 1940, effective April 1, 2020, and outlined registration requirements.
From April 1, 2020, until September 2021, a voluntary registration scheme was in place. Compulsory registration was scheduled to begin in October 2021 for Class A and B medical devices (until September 2022) and for Class C and D medical devices (until September 2023).
The notification acknowledges that representations have been received from stakeholders citing incomplete preparedness due to disruptions caused by the COVID-19 pandemic. These representations are currently under consideration by the Ministry of Health and Family Welfare.
State/UT Drugs Controllers are requested to ensure an uninterrupted supply of medical devices and patient access while the Ministry considers the stakeholder representations.
The notification is issued by Dr. V. G. Somani, Drugs Controller General of India, on September, 2021. Copies have been sent to all Zonal/Sub-Zonal offices of CDSCO, all Port offices, and all Stakeholders/Associations.
Key Entities Referenced
Central Drugs Standard Control Organisation: A regulatory body under the Ministry of Health and Family Welfare, Government of India, responsible for regulating drugs and medical devices.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
S.O. 648 E: A notification issued by the Ministry of Health and Family Welfare regarding the classification of all medical devices.
G.S.R 102E: A notification issued by the Ministry of Health and Family Welfare regarding registration requirements for medical devices.
Class A Medical Devices: A category of medical devices based on risk classification, subject to compulsory registration scheme.
Class B Medical Devices: A category of medical devices based on risk classification, subject to compulsory registration scheme.
Dr. V. G. Somani: Drugs Controller General of India.
F. No. 29/Misc/03/2021-DC (28)
Central Drugs Standard Control Organisation
Government of India
Ministry of Health and Family Welfare
Rik
FDA Bhawan, New Delhi
Dated thexs’September, 2021
To
All the States/UTs Drugs Controllers
Subject: Registration and Labelling requirements of Medical Devices -
Regarding.
As you are aware that, Ministry of Health & Family Welfare (MoHFW) has
issued 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,
as under, which is effective from 01.04 2020. The Ministry has also issued notification
G.S.R 102(E) dated 11.02.2020, regarding registration requirements for such medical
devices which is effective from 01.04 2020.
As per the notification, from 01.04.2020 till September 2021, such Medical
Devices will be under voluntary registration scheme. Thereafter, from October, 2021-
Class A & B Medical Devices will be under compulsory registration scheme up to
September- 2022 and Class C & D Medical Devices will be under compulsory
registration scheme up to September-2023.
Various representations have been received recently from stakeholders
informing that complete preparedness of Industry in this regard remains to be
achieved, in light of disruption due to COVID-19 pandemic situation.
The representations are under consideration of Ministry of Health and Family
welfare, Govt. of India. You are requested to take note of the same with a view to
ensure uninterrupted supply of such medical devices and access to the patients till a
decision is taken on the representations.
Vs
(Dr. V. G. Somani)
Drugs Controller General (India)
Copy to:
1. All Zonal/Sub-Zonal offices of CDSCO
2. All Port offices.
3. All Stakeholders/Associations.