The Central Drugs Standard Control Organisation has issued a draft list of revised risk-based classification of cardiovascular and neurological devices, and has asked the stakeholders to share their responses in 30 days.
As per the notice issued by the DCGI, all concerned associations/stakeholders are requested to forward their comments by filling out a Google form that is provided with the notice within 30 days of the publication of this draft (April 1, 2025).
The draft list attached to the notice includes a total of 553 devices, 351 cardiovascular and 202 neurological related devices.
The notice from the CDSCO published on April 1, 2025 mentions that as per the notification vide S.O. 648(E) dated February 11, 2025, all medical devices are regulated under the Medical Devices Rule (MDR) 2017. According to the MDR 2017 Chapter 2, Rule 4(3), the Central Licensing Authority needs to classify such medical devices as per the risk-based approach.
In this regard, the existing classification list in the cardiovascular and neurological categories has been revisited, and new entries have been added based on their classification as per the First Schedule (Part I) of the MDR 2017.