India – India’s medical device regulators adopt amendment regarding cancellation and suspension of licenses

If you are a medical device manufacturer or supplier you will want to make sure to comply with the latest rules in order to avoid suspension or cancellation of your license to import, sell or distribute medical devices in India.

The Medical Devices (Third Amendment) Rules, 2022 adds Rule 43A to the MDR 2017, which allows the Central Licensing Authority to cancel a license, suspend the license for a period, or direct the licensee to stop the import, sale or distribution of a medical device covered under the license if the manufacturer or licensee fails to comply with any of the conditions of the Import License, or any provisions of The Drugs and Cosmetics Act, 1940 or the MDR 2017…