BIS to develop standards for 214 critical medical devices by 2025 end

New Delhi, Nov 25 (IANS) In a bid to address the growing need for reliable and affordable medical assistive technology, the Bureau of Indian Standards (BIS) is developing standards for 214 critical medical devices, the Ministry of Consumer Affairs, Food & Public Distribution said on Monday.

The national standards body is expected to develop standards for innovative products such as “therapeutic footwear, portable ramps, braille displays, and fall detectors”. The standardisation is “in line with the National Medical Device Policy, 2023’ and will be developed by December 2025, the ministry informed.

The 214 critical medical devices, identified in consultation with the Department of Pharmaceuticals (DoP), also “includes septal closure devices, plasma sterilisers, and phototherapy machines”.

“BIS standards in this sector ensure that Indian medical devices are safe, effective, and globally competitive. These efforts build trust among healthcare providers, consumers, and international stakeholders while solidifying India’s reputation as a leader in healthcare innovation,” the ministry said.

“By aligning with the Medical Devices Rules, 2017, and the National Medical Device Policy, 2023, BIS is proving to be instrumental in establishing a robust regulatory framework that prioritizes public safety while fostering innovation,” it added.

Currently, there are over 1,700 standards for the medical sector, covering specialties such as cardiology, neurology, orthopaedics, ophthalmology, and more.

Of these, around 1,200 standards specifically focus on medical devices critical to healthcare. This includes life-saving devices like cardiac pacemakers, heart valves, ventilators, and haemodialysis machines; advanced diagnostic tools like X-ray machines, CT scanners, MRI systems, and blood glucose monitors; and assistive technology tools like hearing aids, wheelchairs, Jaipur Foot, and tactile pathways for visually impaired individuals.

The ministry noted dentistry has the maximum number of standards (249), followed by surgical disposables (205), orthopaedics (155), and assistive products (152). ENT (70), gynaecology (70), and cardiology (69) have the lowest number of standards.

–IANS

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