Medical Devices Rules

A high-level inter-departmental committee has begun discussions on regulating refurbished medical devices, balancing patient safety concerns with affordable healthcare access

Under the new regulation, medical devices under' class C' and 'class D' cannot be sold without a manufacturing licence after October 1

Seek a separate 'Medical Devices Act' distinct from the drug regulations Bill

Allows self declaration on portal for licensing purposes

Centre has taken a key initiative to support the medical devices industry to reach its potential in the coming years under the "Promotion of Medical Device Parks" scheme

The proposed body will be separate from the Central Drugs Control Standard Organisation, which will continue to be the regulator for drugs

This will be on the lines of the Drugs Technical Advisory Board (DTAB), which looks into issues in the pharmaceuticals sector

FAQs: Decoding the Medical Devices Rules, 2017