The Bureau of Indian Standards (BIS) will prioritize the development of standards for 214 critical medical devices

The Bureau of Indian Standards (BIS), India’s National Standards Body, is responding to the growing need for reliable and affordable medical assistive technology. It is developing standards for innovative products like therapeutic footwear, portable ramps, braille displays, and fall detectors, which aim to enhance the quality of life for individuals with disabilities.

In alignment with the National Medical Device Policy, 2023, BIS is focusing on the development of standards for 214 critical medical devices. These devices, identified in collaboration with the Department of Pharmaceuticals (DoP), include septal closure devices, plasma sterilizers, and phototherapy machines. This initiative is expected to be completed in phases by December 2025.

BIS is also working to improve healthcare quality, safety, and reliability by establishing robust standards for medical devices and services. By aligning with the Medical Devices Rules, 2017, and the National Medical Device Policy, 2023, BIS is playing a key role in developing a regulatory framework that prioritizes public safety while fostering innovation in the medical sector.

To date, BIS has published over 1,700 standards for the medical sector, covering various specialties such as cardiology, neurology, orthopaedics, ophthalmology, and more. Of these, approximately 1,200 standards focus specifically on critical medical devices, including:

• 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.
• Assistive technology: Hearing aids, wheelchairs, Jaipur Foot, and tactile pathways for the visually impaired.

These standards ensure that Indian medical devices are safe, effective, and globally competitive, fostering trust among healthcare providers, consumers, and international stakeholders, while enhancing India’s reputation as a leader in healthcare innovation.

Key Standards for Medical Devices:

Some of the key Indian Standards developed by BIS include:

1. Cardiac Pacemakers: IS 13450 (Part 2/Sec 31): 2021
2. Heart Valves: IS 17840
3. Hip and Knee Implants: IS 12375
4. Ventilators: IS 13450 (Part 2/Sec 12): 2023
5. Infant Incubators and Radiant Warmers: IS 13450 (Part 2/Sec 19): 2023 for incubators and IS 13450 (Part 2/Sec 21): 2023 for radiant warmers
6. Haemodialysis Machines: IS 13450 (Part 2/Sec 16): 2019
7. Infusion Pumps: IS 13450 (Part 2/Sec 24): 2019

Advanced Diagnostic Tools:

• X-ray and CT Machines: IS 7620 (Part 1): 1986
• MRI Systems: IS 13450 (Part 2/Sec 33): 2018
• Ultrasound Devices: IS 13450 (Part 2/Sec 37): 2019
• ECG: Covered under IS 13450 (Part 2/Sec 25): 2018

Monitoring Devices:

• Blood Pressure Monitors: IS 13450 (Part 2/Sec 34): 2019
• Blood Glucose Monitors: IS/ISO 15197: 2013
• Pulse Oximeters: IS/ISO 80601-2-61: 2017

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Source of Information: https://pib.gov.in/PressReleasePage.aspx?PRID=2076855#:~:text=In%20line%20with%20the%20National,plasma%20sterilizers%2C%20and%20phototherapy%20machines.