India, March 10 -- The Government of India has issued a release:
The Central Drugs Standard Control Organisation (CDSCO) has regulatory pathway for regulation of all medical devices which covers Artificial Intelligence (AI)-enabled medical devices. The technical documentation requirements for high-risk medical devices are prescribed under the provisions of the Medical Devices Rules, 2017.
In respect of AI-enabled medical devices, the applicant is required to submit comprehensive technical documentation in accordance with the said rules. The key technical documentation requirements include:
The Chapters IV and V of the Medical Devices Rules, 2017 contain provisions relating to the grant of manufacturing licences and import licences, respe...