The Central Drugs Standard Control Organisation (CDSCO) has released a draft document outlining the revised risk-based classification of cardiovascular and neurological medical devices. The regulatory body has invited industry stakeholders to review and submit their feedback within 30 days of the draft’s publication, which was issued on April 1, 2025.
According to the notice from the Drugs Controller General of India (DCGI), all relevant associations and stakeholders are encouraged to provide their comments by completing a Google Form linked in the announcement. The draft classification list includes a total of 553 medical devices, comprising 351 cardiovascular and 202 neurological devices.
The notice refers to the earlier notification (S.O. 648(E)) dated February 11, 2025, which states that all medical devices are regulated under the Medical Devices Rules (MDR), 2017. As per Chapter 2, Rule 4(3) of the MDR 2017, the Central Licensing Authority is responsible for classifying medical devices based on their risk level. In line with this requirement, the CDSCO has reviewed and updated the existing classification of cardiovascular and neurological devices, incorporating new entries as per the First Schedule (Part I) of the MDR 2017.
In its announcement, the regulatory body emphasized that the revised classification follows a risk-based approach. It has modified the existing list of cardiovascular and neurological medical devices and introduced additional entries in accordance with the MDR 2017 guidelines.
The draft list categorizes the 553 medical devices into different risk classes. The majority, 221 devices, fall under Class D (highest risk), followed by 153 devices in Class B, 151 in Class C, and 25 in Class A (lowest risk).
As per the CDSCO’s notice, this classification update aligns with the provisions outlined in Chapter II, Rule 4(3) of the MDR 2017. The risk-based classification of medical devices follows the standards set under the First Schedule of MDR-2017 and the guidelines established by the International Medical Device Regulators Forum (IMDRF) Global Harmonization Task Force (GHTF).
Currently, the CDSCO categorizes medical devices into four classes—A, B, C, and D—based on their risk level, with Class A representing the lowest risk and Class D the highest. To facilitate industry input, CDSCO has provided a Google Form for submitting feedback on the draft document. All responses must be submitted within the designated 30-day period.
