BIS announces 214 medical devices to have Indian Standards by 2025

The Bureau of Indian Standards (BIS) on Monday said it is going to prioritise the development of standards for 214 critical medical devices, which are expected to be completed by December 2025. This initiative aligns with the National Medical Device Policy, of 2023, and aims to enhance the safety, efficacy, and global competitiveness of Indian medical devices.

The medical devices identified for prioritisation include septal closure devices, plasma sterilizers, and phototherapy machines, which are critical to healthcare delivery. 

These devices have been selected in consultation with the Department of Pharmaceuticals to address the growing need for standardisation in the medical sector.

BIS, India’s national standards body, is also focusing on innovative products that provide support for individuals with disabilities.  Among these are therapeutic footwear, portable ramps, braille displays, and fall detectors. 

These advancements are expected to significantly improve accessibility and quality of life for people with disabilities. Till now, BIS has published over 1,700 standards for the medical sector.

These standards encompass a wide range of specialities, including cardiology, neurology, orthopaedics, and ophthalmology.  Approximately 1,200 of these standards specifically focus on medical devices critical to healthcare.

The development of standards plays a vital role in ensuring that medical devices in India meet stringent safety and performance criteria. 

By adhering to BIS standards, Indian manufacturers can produce devices that are not only safe and effective for domestic use but also competitive in the global market.

This initiative by BIS ensures its commitment to strengthening the healthcare infrastructure in India by supporting the production of high-quality medical devices.  BIS standards in this sector ensure that Indian medical devices are safe, effective, and globally competitive.