CDSCO issues revised risk classification list for cardiovascular devices

Industry stakeholders asked to submit feedback to draft list by April 30

The Central Drugs Standard Control Organisation (CDSCO), which is the highest regulatory body for drugs, cosmetics and medical devices in India, has issued an updated draft list of revised risk-based classifications for devices in the cardiovascular and neurological domains.

 

In a notice dated April 1, the Drugs Controller General of India (DCGI) stated that the revision in risk-based classification in the two categories is being done in accordance with the Medical Device Rules (MDR), 2017.

 

“In this regard, existing classification lists in the categories have been revisited and new entries have been added based on their classification as per the First Schedule (Part 1) of the MDR, 2017,” the apex drug regulator added.

 

The updated draft list includes a total of 553 devices, of which 351 are from the cardiovascular category, whereas the other 202 are neurological devices.

 

Of these, 372 devices – such as aortic annuloplasty rings and biological heart valve implants – have been classified under high-risk classes, whereas 181 other devices have been kept as low-risk.

 

These include devices such as cardiac mapping system reference patches and cerebrospinal fluid catheter tubing sets.

 

The CDSCO has also asked the industry and other stakeholders to submit their feedback on the revised classifications within 30 days of the order.

 

All medical devices in India are governed under the MDR, 2017, which classifies devices as high-risk (Class C and D) and low-risk (Class A and B). Currently, there are 24 categories of medical devices classified into these four classes.

 

Commenting on the development, an industry executive said that risk-based reclassification would provide clarity and alignment for both regulators and manufacturers during the submission of licensing applications.

 

Rajiv Nath, forum coordinator for the Association of Indian Medical Device Industry (AIMED), added that such clarity in regulatory expectations fosters predictable market demand and improves profit margins, which in turn drives innovation and enhances patient safety.

 

While the industry has welcomed the risk-based reclassification of medical devices by the CDSCO, it has also urged the apex regulatory body to bring more clarity for regulatory compliance.

 

“We still find huge variances in the interpretation of MDR between various state and central government regulators, as manufacturers wade through lengthy regulatory approval hurdles,” the executive quoted above said.