CDSCO Releases Revised Risk Classification List for Cardiovascular Devices

According to a notice issued by the Drugs Controller General of India (DCGI) on April 1, the revised list now includes a total of 553 devices.

The Central Drugs Standard Control Organisation (CDSCO) has issued an updated draft list of risk-based classifications for medical devices in the cardiovascular and neurological categories.

The revision aligns with the Medical Device Rules (MDR), 2017, and is aimed at re-evaluating existing classifications while incorporating new entries.

According to a notice issued by the Drugs Controller General of India (DCGI) on April 1, the revised list now includes a total of 553 devices. Of these, 351 fall under the cardiovascular category, while 202 belong to the neurological domain.

The risk assessment has resulted in 372 devices being classified as high-risk, including aortic annuloplasty rings and biological heart valve implants, whereas 181 devices have been placed in the low-risk category.

The CDSCO has invited industry stakeholders to submit feedback on the updated classifications by April 30, providing a 30-day window for review and suggestions.

Implementation Under Medical Device Rules, 2017

The DCGI emphasized that the reclassification process is in accordance with the First Schedule (Part 1) of the 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 regulator stated.

The move is expected to bring greater clarity to the regulatory framework governing medical devices, particularly those used in critical cardiovascular and neurological interventions.

Stakeholders, including manufacturers and healthcare professionals, are encouraged to provide inputs to ensure a comprehensive evaluation of the proposed classifications.

Next Steps & Industry Response

With the submission deadline set for April 30, industry representatives and medical experts are expected to analyze the implications of the revised classifications.

The regulatory update is likely to influence market dynamics for high-risk medical devices, affecting manufacturing standards, compliance requirements, and approval processes.

The CDSCO’s revised classification is part of broader efforts to strengthen medical device regulation in India. As per existing norms, medical devices are categorized based on their intended use and associated risks, ensuring appropriate oversight for patient safety and clinical efficacy.