NEW DELHI, Oct. 9 -- India has overhauled its medical device safety-monitoring framework, bringing software glitches, cybersecurity risks and artificial intelligence (AI)-enabled technologies into routine surveillance while expanding reporting beyond major hospitals to primary health centres and village clinics.

The revised guidelines, developed by the Indian Pharmacopoeia Commission (IPC) following safety recommendations from the World Health Organization (WHO), introduce a 100-point scoring metric to assess reporting quality across 775 monitoring centres nationwide, according to two government officials familiar with the development and a document reviewed by Mint.

The revised guidelines have been circulated to state governments for i...