On 25th November 2024, the Bureau of Indian Standards (BIS) declared standards for 214 critical medical devices to be developed with phased completion targeted before December 2025. This falls in the National Medical Device Policy, 2023, and was identified in consultation with the Department of Pharmaceuticals.
Table of Contents
Focus on Innovative Products
BIS is also drawing up standards for new emerging products for persons with disabilities like therapeutic footwear, foldable ramps, braille displays, fall detectors, etc.
Comprehensive Standards Coverage
BIS has issued over 1,700 standards in the medical sector, including cardiology, neurology, orthopedics, and ophthalmology. Of these, around 1,200 specific standards relate to critical medical devices.
Safety and Competitiveness
The development of these standards ensures that Indian medical devices are safe, effective, and globally competitive, which will help to see better healthcare outcomes and foster trust in Indian medical products. By way of rigorous testing and certification, the BIS standards will enhance the quality and reliability of medical devices in India.
This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.
