Pursuant to the discussions in the meeting of the Drugs Technical Advisory Board (Board) constituted under Drugs and Cosmetics Act, 1940, the Drugs Controller General of India is contemplating amending the Medical Devices Rules, 2017 (Rules) to include provisions on quality control requirements for non-sterile and non-invasive medical devices. 

These devices form part of ‘Class A’ medical devices, as set out in the first schedule of the of the Rules (such as thermometers, stethoscope, elastic bandages, and non-electrical wheelchairs), for which quality control measures have not yet been prescribed and accordingly, manufacturing and export of such devices currently mandates no license requirements.  

As a result, it was opined by the Board that a provision of undertaking setting out that the manufacturing facility has complied with the quality management system will be incorporated in the Rules. The updated Rules are yet to be issued to account for the above. Link (Agenda 8)