New Delhi: The nodal licensing and regulatory physique for medical devices, CDSCO, has issued the draft record of revised threat-based mostly classification of devices within the cardiovascular and neurological domains and has requested stakeholders to share their responses inside 30 days.
Making the announcement, the apex regulatory physique acknowledged, “Below the danger-based mostly method, the Central Licensing Authority (CDSCO) has revised the prevailing classification record of cardiovascular and neurological gadget classes and has added new lists based mostly on their classification as per the First Schedule (Half 1) of the MDR, 2017.”
As per the discover issued by the workplace of the Medicine Controller Normal of India (DCGI), “The draft of the classification lists is annexed for finalization, and associations/stakeholders are requested to ahead their comments inside 30 days from the date of publication of this draft, i.e., April 1, 2025.”
The draft record hooked up to the discover features a complete of 553 devices—351 cardiovascular and 202 neurological-associated medical devices.
Of the overall 553 devices listed within the draft, a most of 221 fall below Class D, adopted by Class B with 153, Class C with 151, and 25 devices in Class A.
In line with the CDSCO discover, the revision within the gadget classification record has been made in accordance with Chapter II, Rule 4(3) of the MDR (Medical Devices Guidelines), 2017, below which the Central Licensing Authority should classify such medical devices based mostly on a threat-based mostly method.
For submitting comments on the issued draft, CDSCO has offered a Google Kind together with the discover and can settle for responses submitted by way of the shape inside the aforementioned time restrict.
The chance-based mostly classification of medical devices categorizes devices into totally different courses based mostly on potential dangers, as specified below the First Schedule of the MDR-2017 guidelines and the IMDRF International Harmonization Job Drive (GHTF) pointers.
Presently, there are 24 classes of medical devices categorized by CDSCO into 4 courses—A, B, C, and D—the place Class A represents the bottom threat and Class D the very best threat.
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