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CDSCO Releases Draft on Revised Classification of Cardiovascular and Neurological Devices, Seeks Industry Feedback

Announcing the development, CDSCO stated that the updated classification follows a risk-based framework under the Medical Devices Rules (MDR), 2017. The revision, carried out by the Central Licensing Authority, includes modifications to existing categories and the addition of new device classifications as per the First Schedule (Part 1) of MDR, 2017.

CDSCO Releases Draft on Revised Classification of Cardiovascular and Neurological Devices, Seeks Industry Feedback
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The Central Drugs Standard Control Organization (CDSCO), India’s key regulatory authority for medical devices, has issued a draft detailing the revised risk-based classification of cardiovascular and neurological medical devices. The regulatory body has invited industry stakeholders to provide feedback within 30 days.

Announcing the development, CDSCO stated that the updated classification follows a risk-based framework under the Medical Devices Rules (MDR), 2017. The revision, carried out by the Central Licensing Authority, includes modifications to existing categories and the addition of new device classifications as per the First Schedule (Part 1) of MDR, 2017.

According to a notice from the Drugs Controller General of India (DCGI), “The draft classification lists are annexed for finalization, and stakeholders are encouraged to submit their comments within 30 days from the publication date, i.e., April 1, 2025.”

Breakdown of Device Classification

The draft document lists 553 medical devices—351 related to cardiovascular care and 202 for neurological applications. Among these, 221 devices are classified as Class D (highest risk), followed by 153 in Class B, 151 in Class C, and 25 in Class A (lowest risk).

The classification update aligns with Chapter II, Rule 4(3) of MDR, 2017, which mandates that medical devices be categorized based on potential risk levels. This approach is consistent with global standards, including the IMDRF Global Harmonization Task Force (GHTF) guidelines.

Call for Industry Input

To facilitate industry participation, CDSCO has provided a Google Form for stakeholders to submit their responses. The regulatory body will accept comments exclusively through this platform within the stipulated timeframe.

Currently, CDSCO classifies medical devices into 24 categories, grouping them into four risk-based classes—Class A (lowest risk), Class B, Class C, and Class D (highest risk). The ongoing revision aims to enhance regulatory clarity and ensure the safety and efficacy of medical devices in India.

With industry feedback playing a crucial role in finalizing these classifications, stakeholders are encouraged to review the draft and share their insights before the deadline.