BIS Develops Standards for Medical Assistive Technology & Devices

Under the National Medical Device Policy 2023, BIS has identified 214 critical medical devices in consultation with the DoP.

The Bureau of Indian Standards (BIS), India’s national standards body, is taking significant steps to address the growing need for reliable and affordable medical assistive technology.

The initiative aims to support individuals with disabilities and improve their quality of life, the Ministry of Consumer Affairs, Food & Public Distribution announced on Monday.

BIS is working on standards for innovative products such as therapeutic footwear, portable ramps, braille displays, and fall detectors. These advancements align with the government’s broader efforts to enhance accessibility and inclusivity in healthcare.

Standards for Critical Medical Devices

Under the National Medical Device Policy 2023, BIS has identified 214 critical medical devices in consultation with the Department of Pharmaceuticals (DoP).

The list includes devices such as septal closure devices, plasma sterilizers, and phototherapy machines. The phased development of standards for these devices is set to be completed by December 2025.

BIS’s initiatives align with the Medical Devices Rules 2017 and focus on improving the quality, safety, and reliability of medical devices and services.

By establishing a robust regulatory framework, BIS aims to ensure public safety while fostering innovation in the medical sector.

Comprehensive Standards Published

To date, BIS has published over 1,700 standards for the medical sector, covering areas like cardiology, neurology, orthopedics, and ophthalmology.

Of these, around 1,200 standards specifically focus on critical medical devices such as cardiac pacemakers, ventilators, MRI systems, and assistive technologies like hearing aids and tactile pathways for visually impaired individuals.

By developing these standards, BIS ensures that Indian medical devices are safe, effective, and globally competitive, strengthening trust among stakeholders and solidifying India’s position in healthcare innovation.

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