The first meeting of the restructured National Medical Device Promotion Council (NMDPC) recently addressed significant concerns in the Medical Technology (MedTech) industry. The meeting covered updates from Central Drugs Standards and Control Organisation (CDSCO) and the State Licensing Authorities (SLAs) to smooth the transition to licensing for Class A and B Medical Devices, effective 1st October 2022.
Medical Devices Classification Scheme
Under the Medical Devices Rules of 2017, medical devices are classified as Class A (low risk), e.g., absorbent cotton balls, alcohol swabs; Class B (low moderate risk), such as thermometers, blood pressure monitoring devices; Class C (moderate high risk), e.g., implants, and Class D (high-risk), such as heart valves.
Government Initiatives for Promoting the MedTech Industry
The Department of Pharmaceuticals has taken numerous initiatives, including a 100% Foreign direct Investment (FDI) in the MedTech Sector on an automatic route, Production-Linked Incentive (PLI) scheme for Medical Devices. Furthermore, Medical Devices Parks are being established in four Indian states: Himachal Pradesh, Tamil Nadu, Madhya Pradesh, and Uttar Pradesh.
Challenges Within the MedTech Industry
Concerns include the regulatory burden of labeling requirements for Medical Devices and insufficient certified Medical Device Testing Laboratories. Also, the Indian Medical Devices Industry currently lacks adequate research ecosystem and infrastructure to manufacture advanced medical devices, particularly Class C & D devices.
NMDPC’s Recommendations for Tackling Challenges
To address these issues, NMDPC recommended harmonizing the labeling provisions of medical devices under existing rules. They also advised greater investment in Medical Devices Parks and increased participation in the upcoming National MedTech Expo, 2022.
It underscored the need for more certified Medical Devices Testing Laboratories and a robust post-market surveillance system. They proposed new legislation to set up regulators at different levels for regulating the industry, incorporating scientific institutes to test medical devices for safety and efficacy.
Regarding incentives, they suggested a Research-Linked Incentive (RLI) Scheme akin to the PLI scheme. Upskilling Medical Device Officers, establishing a single-window clearing platform for license applications, and instituting a comprehensive approval system were also put forth.
About NMDPC
Chaired by the Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, NMDPC includes members from stakeholder departments/organizations affecting sector growth. It also includes multiple medical device industry associations representing the sector in India.
NMDPC is expected to become a vibrant forum for all issues related to the medical devices sector, positioning it as a sunrise sector with immense potential for addressing social obligations and economic aspirations of India.
Last Modified: February 18, 2024