How To Read Legislation

Indian legislation is published in the Official Gazette of India (egazette.gov.in). CDSCO circulars and office memoranda are published on the CDSCO website.

The Medical Devices Rules 2017 is available at the CDSCO medical devices rules page.

In addition to the Medical Devices Rules 2017, medical device companies must reference Indian Standards (IS) published by BIS (Bureau of Indian Standards) that specify technical requirements for various device categories. These standards are often referenced in device approvals and must be followed for manufacturing and testing.