The Bureau of Indian Standards (BIS) on Monday said it will prioritize the development of standards for 214 essential medical devices, which is expected to be completed by December 2025. The program is in line with the National Medical Device Policy, 2023, and aims to improve safety, efficiency, and competitiveness of the world of medical devices in India.
Medical devices identified to be prioritized include septal closure devices, plasma sterilizers, and phototherapy devices, which are critical to the delivery of health care.
These devices were selected in consultation with the Department of Medicine to address the growing need for standardization in the medical field.
BIS, India’s national standards body, is also focusing on innovative products that provide support to people with disabilities. Among these are therapeutic shoes, portable ramps, braille displays, and amputations.
This development is expected to significantly improve accessibility and quality of life for people with disabilities. To date, BIS has published more than 1,700 standards for the medical sector.
These levels cover a variety of specialties, including cardiology, neurology, orthopedics, and ophthalmology. About 1,200 of these standards focus exclusively on medical devices essential to health care.
Development of standards plays an important role in ensuring that medical devices in India meet strict safety and performance criteria.
By adhering to BIS standards, Indian manufacturers can produce safe and effective devices not only for domestic use but also compete in the global market.
This move by BIS reaffirms its commitment to strengthening India’s healthcare infrastructure by supporting the production of high-quality medical devices. BIS standards in this field ensure that Indian medical devices are safe, effective, and globally competitive.
