The Indian government has announced a revision of the risk-based classification lists for medical devices in the Cardiovascular and Neurological categories, and is seeking public input before finalization. This notice was issued on April 1, 2025.
As per the notification dated February 11, 2020, all medical devices in India are regulated under the Medical Devices Rules (MDR), 2017. In accordance with Rule 4(3) of Chapter II of the MDR 2017, the Central Licensing Authority is required to classify these devices based on a risk-based approach.
Therefore, the government has revisited the existing classification lists for Cardiovascular and Neurological medical devices and added new entries based on their classification as outlined in the First Schedule (Part I) of the MDR, 2017.
Categories of Medical Devices Under Revision:
- Cardiovascular
- Neurological
This revision aims to ensure that the classification of medical devices accurately reflects their potential risks to patients and users. This is crucial for maintaining patient safety and ensuring the effective regulation of medical devices in India.
To ensure a comprehensive and transparent process, the government is seeking input from all concerned associations and stakeholders. The draft of the revised classification lists is available for review, and stakeholders are encouraged to provide their comments.
Stakeholders can submit their comments by filling out a Google form.
The deadline for submitting comments is May 1, 2025.
