What is the role of BIS in the Indian medical device industry?

BIS is responsible for developing and enforcing standards for medical devices in India. This helps to ensure that these devices are safe, effective, and reliable.

How does BIS ensure the quality of medical devices?

BIS develops and implements stringent quality standards for medical devices. It also conducts regular inspections of manufacturing facilities to ensure compliance with these standards.

Standards for 214 Critical Medical Devices to be developed

BIS has already published over 1,700 standards for the medical sector, covering a wide range of specialties.

The Health Master

December 1, 2024

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Last Updated on December 1, 2024 by The Health Master

Standards

The Bureau of Indian Standards (BIS), India’s national standards body, is taking significant strides to improve the quality, safety, and affordability of medical devices in the country.

This move is in direct response to the growing demand for reliable and accessible healthcare solutions, particularly for individuals with disabilities.

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Prioritizing Standards for Critical Medical Devices

As part of the National Medical Device Policy 2023, BIS has identified 214 critical medical devices, including septal closure devices, plasma sterilizers, and phototherapy machines, that will be prioritized for standards development.

This initiative, which aims to be completed by December 2025, will ensure that these essential devices meet stringent quality and safety standards.

Enhancing Accessibility with Assistive Technology Standards

BIS is also developing standards for innovative assistive technologies, such as therapeutic footwear, portable ramps, braille displays, and fall detectors.

These devices can significantly improve the quality of life for individuals with disabilities by providing them with greater independence and mobility.

Download standards for Medical Devices

Building a Robust Regulatory Framework

By aligning with the Medical Devices Rules 2017 and the National Medical Device Policy 2023, BIS is playing a crucial role in establishing a robust regulatory framework for medical devices in India.

This framework will help to ensure that medical devices are safe, effective, and accessible to all.

Key BIS Standards for Medical Devices

BIS has already published over 1,700 standards for the medical sector, covering a wide range of specialties.

Some of the key standards developed by BIS 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
Assistive technology: Hearing aids, wheelchairs, Jaipur Foot, and tactile pathways for visually impaired individuals

Some of the key Indian standards developed by BIS

Cardiac Pacemakers: IS 13450 (Part 2/Sec 31): 2021
Heart Valves: IS 17840
Hip and Knee Implants: IS 12375
Ventilators: IS 13450 (Part 2/Sec 12): 2023
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
Haemodialysis Machines: IS 13450 (Part 2/Sec 16) : 2019
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

By prioritizing standards development, promoting innovation, and enforcing regulations, BIS is working to make India a global leader in the medical device industry.

Also read following FAQs

What is the role of BIS in the Indian medical device industry?

BIS is responsible for developing and enforcing standards for medical devices in India. This helps to ensure that these devices are safe, effective, and reliable.
How does BIS ensure the quality of medical devices?

BIS develops and implements stringent quality standards for medical devices. It also conducts regular inspections of manufacturing facilities to ensure compliance with these standards.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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