India publishes new circular on medical devices.
On 16 May 2024, the Ministry of Health & Family Welfare (MoHFW) issued a notification dated 11 February 2020, which specifies that all medical devices are now categorized under sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940, which is effective from 1 April 2020.
Notification S.O. 648 (E)
This notification declares that all medical devices will be categorized as “drugs” under the Drugs and Cosmetics Act, 1940.
This categorization falls under sub-clause (iv) of clause (b) of Section 3 of the Act. This sub-clause generally refers to devices intended for use in the diagnosis, treatment, mitigation, or prevention of disease or disorder in human beings.
Notification under G.S.R. 102(E)
On 11 February 2020, the MoHFW released notification no. G.S.R. 102 (E) to regulate medical devices in a phased manner. According to this notification, Class C and Class D medical devices are subject to a licensing regime from 1 October 2023.
G.S.R. 102(E) aims to establish a comprehensive regulatory framework for all medical devices, ensuring that they meet essential standards of quality, safety and efficacy.
Class C & D Devices
The notification specifies that Class C and Class D medical devices, which are typically more complex and higher risk, will be required to comply with the licensing regime from 1 October 2023. These are typically more complex and increased regulatory oversight is critical for these high-risk devices.
Licensing Regime for Class C & D Devices (Effective from 1 October 2023)
In response to concerns raised by various associations and stakeholders about potential disruptions to business operations due to the licensing requirements for Class C and Class D medical devices starting on 1 October 2023, the following decision has been made:
If an existing importer or manufacturer is already importing or manufacturing any Class C or Class D medical devices and has submitted an application for an import or manufacturing license to the Central Licensing Authority by 30 September 2023, their application will be considered valid. These applicants may continue to import or manufacture the specified devices for up to three months from the issuance of this order, or until the Central Licensing Authority makes a decision on the application, whichever is earlier.
For more details, please visit cdsco.gov.in.
We acknowledge that the above information has been compiled from Central drugs Standard Control Organisation (CDSCO).
