The Central Licensing Authority (CLA) under the Ministry of Health and Family Welfare has announced updates to existing risk-based classification lists for medical devices. This move aims to ensure consistent and accurate classification of medical devices as per the Medical Devices Rules (MDR), 2017.
It may be recalled that the Ministry of Health & Family Welfare (MoHFW) had published a notification dated February 11, 2020 bringing all medical devices under the ambit of the Drugs and Cosmetics Act, 1940. This notification was effective from April 1, 2020.
Rule 4(3) of the MDR mandates the CLA to classify these devices based on a risk-based approach.
The CLA has reviewed and updated classification lists for four specific categories:
- Interventional Radiology
- Radiotherapy
- Oncology
- Class A (non-sterile and non-measuring) medical devices
Drafts of the revised classification lists are available for public review. Stakeholders, including industry associations and medical professionals, are encouraged to provide feedback through the dedicated Google Form by February 5, 2025.
Following the feedback period, the CLA will finalize and publish the updated classification lists.
This initiative reflects the government’s commitment to a robust medical device regulatory framework that prioritizes patient safety while fostering innovation in the medical device sector.
