In line with the National Medical Device Policy, 2023, the Bureau of Indian Standards (BIS) is prioritising standards development for 214 critical medical devices.
Representational Image
In line with the National Medical Device Policy, 2023, the Bureau of Indian Standards (BIS) is prioritising standards development for 214 critical medical devices. These have been identified in consultation with the Department of Pharmaceuticals (DoP). It includes septal closure devices, plasma sterilizers, and phototherapy machines. The initiative is set for phased completion by December 2025.
The BIS, India’s National Standards Body, is addressing the growing need for reliable and affordable medical assistive technology. It is developing standards for innovative products such as therapeutic footwear, portable ramps, braille displays, and fall detectors, which support individuals with disabilities and enhance their quality of life.
The Bureau is also driving improvements in healthcare quality, safety, and reliability by developing robust medical device and service standards. 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.
Advertisement
It has published over 1,700 standards for the medical sector, covering specialities such as cardiology, neurology, orthopaedics, ophthalmology, and more. Of these, around 1,200 standards specifically focus on medical devices critical to healthcare. They include life-saving devices: Cardiac pacemakers, heart valves, ventilators, and haemodialysis machines, Advanced diagnostic tools: X-ray machines, CT scanners, MRI systems, and blood glucose monitors and Assistive technology: Hearing aids, wheelchairs, Jaipur Foot, and tactile pathways for visually impaired individuals.
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.
Advertisement
