New Delhi: The nodal licensing and regulatory body for medical devices, CDSCO, has issued the draft list of revised risk-based classification of devices in the cardiovascular and neurological domains and has asked stakeholders to share their responses within 30 days.
Making the announcement, the apex regulatory body stated, “Under the risk-based approach, the Central Licensing Authority (CDSCO) has revised the existing classification list of cardiovascular and neurological device categories and has added new lists based on their classification as per the First Schedule (Part 1) of the MDR, 2017.”
As per the notice issued by the office of the Drugs Controller General of India (DCGI), “The draft of the classification lists is annexed for finalization, and associations/stakeholders are requested to forward their comments within 30 days from the date of publication of this draft, i.e., April 1, 2025.”
The draft list attached to the notice includes a total of 553 devices—351 cardiovascular and 202 neurological-related medical devices.
Of the total 553 devices listed in the draft, a maximum of 221 fall under Class D, followed by Class B with 153, Class C with 151, and 25 devices in Class A.
According to the CDSCO notice, the revision in the device classification list has been made in accordance with Chapter II, Rule 4(3) of the MDR (Medical Devices Rules), 2017, under which the Central Licensing Authority must classify such medical devices based on a risk-based approach.
For submitting comments on the issued draft, CDSCO has provided a Google Form along with the notice and will accept responses submitted through the form within the aforementioned time limit.
The risk-based classification of medical devices categorizes devices into different classes based on potential risks, as specified under the First Schedule of the MDR-2017 rules and the IMDRF Global Harmonization Task Force (GHTF) guidelines.
Currently, there are 24 categories of medical devices classified by CDSCO into four classes—A, B, C, and D—where Class A represents the lowest risk and Class D the highest risk.
