The Bureau of Indian Standards (BIS) is working on creating standards for 214 vital medical devices in line with the National Medical Device Policy, 2023. This initiative aims to address the rising demand for safe and affordable medical assistive technology in India. The BIS plans to have these standards ready by December 2025, as announced by the Union Ministry of Consumer Affairs, Food & Public Distribution.
Among the devices to be standardized are innovative products such as therapeutic footwear, portable ramps, braille displays, and fall detectors. The 214 critical medical devices, identified in consultation with the Department of Pharmaceuticals (DoP), also include septal closure devices, plasma sterilisers, and phototherapy machines.
The Ministry emphasized that BIS standards ensure that Indian-made medical devices are not only safe and effective but also globally competitive. These standards build trust among healthcare providers, consumers, and international stakeholders, reinforcing India's growing leadership in healthcare innovation.
In line with the Medical Devices Rules, 2017, and the National Medical Device Policy, 2023, BIS is playing a key role in creating a strong regulatory framework that prioritizes public safety while encouraging technological advancements.
Currently, the medical sector in India follows over 1,700 standards across various specialties, including cardiology, neurology, orthopaedics, and ophthalmology. Of these, approximately 1,200 standards are specifically related to medical devices essential to healthcare.
These standards cover life-saving devices such as cardiac pacemakers, heart valves, ventilators, and haemodialysis machines. They also include advanced diagnostic tools like X-ray machines, CT scanners, MRI systems, and blood glucose monitors, as well as assistive technology products like hearing aids, wheelchairs, Jaipur Foot, and tactile pathways for visually impaired individuals.
The Ministry also highlighted that dentistry has the highest number of standards (249), followed by surgical disposables (205), orthopaedics (155), and assistive products (152). Fields like ENT (70), gynaecology (70), and cardiology (69) have comparatively fewer standards.
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