In its first meeting at the Dr. Ambedkar International Centre in New Delhi, the Department of Pharmaceuticals’ newly formed National Medical Device Promotion Council (NMDPC) received an update on the actions taken by the State Licensing Authorities (SLAs) and the Central Drugs Standards and Control Organization (CDSCO) to ensure a smooth transition to licensing of Class A and B Medical Devices beginning on October 1, 2022.
Members of stakeholder departments/organisations, whose activities have an impact on the development of the industry, as well as representatives from several medical device industry associations, which represent the sector in India, make up the council, which is presided over by the Secretary of the Department of Pharmaceuticals. The NMDPC discussed the crucial concerns facing the medtech sector.
The Department of Pharmaceuticals first updated the Council on the status of the various sector-related initiatives it has undertaken, including 100% automatic FDI in the medtech sector, the PLI scheme for medical devices, medical device parks in four states, support for a common infrastructure facility for superconducting magnetic coil testing, etc. By creating permanent forums and hosting regulatory round tables, the department is also collaborating with the medical device companies to reach an understanding on industry-related concerns.
Department of Health and Family Welfare updated the preparedness for transition to licensing of Class-A and Class-B medical devices, w.e.f October 1, 2022, under Medical Devices Rules 2017.
Reducing the regulatory burden of medical device labelling requirements was another significant topic discussed. The council recommended to the health regulator that action be taken to synchronise the labelling requirements for medical devices under the Legal Metrology (Packaged Commodity) Rules, 2011 into Medical Device Rules, 2017, for the licensed medical devices, after discussing the issues with the industry associations.