Health regulator geared up for transition to licensing of medical devices

The reconstituted National Medical Device Promotion Council (NMDPC) under the Department of Pharmaceuticals held its first meeting in New Delhi and was updated on the steps taken up by Central Drugs Standard Control Organisation (CDSCO) and the state licensing authorities for the smooth transition to licensing of class-A and class-B medical devices from October 1.

The NMDPC deliberated on the important issues of the Medtech (medical technology) industry.

The Council under the chair of the Secretary, Department of Pharmaceuticals, has members from stakeholder departments, organisations, functions of which have a bearing on the growth of the sector and has representation from several medical device industry associations, representing the sector in India.

The Department of Pharmaceuticals presented the latest status of the various initiatives taken by it for the sector to the Council such as 100 per cent FDI in MedTech sector on automatic route, PLI scheme for medical devices, medical devices parks in four states, assistance for common infrastructure facility of superconducting magnetic coil testing facility, etc.

The Department of Health and Family Welfare (DoHFW) updated the preparedness for transition to licensing of class-A and class-B medical devices from October 1 under Medical Devices Rules, 2017. The Council appreciated the various efforts done by the CDSCO/DoHFW in rolling out the licensing process of class-A and class-B medical devices.

The Council also heard the views of the industry as well as AERB (Atomic Energy Regulatory Board) and National Accreditation Board for Testing and Calibration Laboratories (NABL) on the requirement of NABL accreditation of in-house laboratories of the manufacturers of specific medical devices on the radiation safety requirements at the manufacturing sites. The industry suggested various issues to be taken up in the subsequent Council meeting.

The Industry Associations' representatives were encouraged to actively engage with states, which were sanctioned medical devices parks by the Department of Pharmaceuticals for creating common infrastructure facilities and come forward to invest in the proposed parks to boost domestic manufacturing.

The industry's support was also solicited for the proposed National MedTech Expo, 2022, being organised by the Department in December 2022 at New Delhi's Pragati Maidan to showcase the strengths and capabilities of Indian medical devices industry involving start-ups, innovators, domestic manufacturers, hospitals etc.