Bis Standards

Official source: Bureau of Indian Standards; IMDRF; QCI ICMED

BIS (Bureau of Indian Standards) publishes Indian Standards (IS) applicable to medical devices. These standards cover quality, safety, and performance requirements for various medical device categories. Compliance with relevant BIS standards is often required under MDR 2017 and supports demonstration of Essential Principles. Common medical device standards include those for sterile products, biocompatibility, electrical safety, and sterilization methods. Refer to the Bureau of Indian Standards website for the complete catalog of medical device-related standards.