The Centre is reclassifying 1,178 medical devices. This move is expected to enhance clarity and support the growth of India’s medical devices market.
New Delhi: In a significant move to improve regulatory uniformity in medical devices, the Indian government plans to classify approximately 1,178 medical devices into four risk-based categories under the Medical Device Rule, 2017.
The Central Drugs Standards Control Organization (CDSCO) is revising the existing list of medical devices. The new classification will include 186 devices for interventional radiology, 114 for radiology therapy, 75 for oncology, and a new category, class A non-sterile and non-measuring medical devices, which encompasses 803 medical equipment.
Ensuring Regulatory Compliance
This streamlined classification process guarantees that each medical device is approved by a State Licensing Authority specific to its category.
Market Growth Projections
India’s medical devices market, currently valued at approximately $11 billion, is projected to grow to $50 billion by 2030, highlighting the sector’s potential.
As the medical devices sector is crucial for healthcare, effective regulation is essential for the prevention, diagnosis, treatment, and management of various medical conditions.
Industry Engagement
Rajeev Singh Raghuvanshi, Drugs Controller General of India, stated that the updated classification reflects both national and international standards. The CDSCO is welcoming feedback from industry stakeholders to ensure comprehensive coverage of medical devices.
Investment in Medical Device Infrastructure
The government has initiated a ₹500 crore scheme aimed at strengthening the medical devices industry, focusing on manufacturing, skill development, and promoting industry growth.
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