CDSCO has released a draft update to the risk-based classification list for *Cardiovascular and Neurological medical devices** under the Medical Devices Rules, 2017. The update outlines revised risk classes (A, B, C, D) for a wide range of devices such as stents, pacemakers, neurostimulators, and aneurysm clips. Stakeholders are invited to provide comments and suggestions on the proposed changes.
The Central Drugs Standard Control Organization (CDSCO) has published a draft document proposing updates to the existing *risk-based classification list for Cardiovascular and Neurological medical devices*. This initiative aligns with the provisions of the *Medical Devices Rules, 2017** and seeks to bring greater clarity and regulatory alignment to medical device classification. The updated list classifies devices such as *coronary stents, prosthetic heart valves, pacemakers, neurosurgical clips, neurostimulators*, and others into risk categories *A, B, C, or D*, depending on their intended use and level of invasiveness. These changes aim to streamline regulatory oversight, support patient safety, and enhance compliance for both domestic manufacturers and importers. CDSCO has invited feedback from stakeholders and industry experts on the draft. Comments should be submitted to the Drugs Controller General (India) within the timeline specified in the draft notification. Along with the updated classification, new devices have been added under the Cardiovascular and Neurological medical device categories.