The Department of Pharmaceuticals (DoP) under Ministry of Chemicals and Fertilizers has released on its website, an Approach Paper for the Draft National Policy for the Medical Devices, 2022.
- Medical Devices, popularly called as MedTech Sector, is expected to grow in market size from the present 11 Bn USD to 50 Bn USD by 2025.
- The Medical Device Sector has remained largely unregulated till 2017 when Medical Device Rules, 2017 were framed by CDSCO for comprehensive regulation of MDs in a phased manner, especially on the quality, safety, and efficacy aspects, under the Drugs and Cosmetic Act, 1940
What is medical device ?
- The medical device is a multi-product sector, with the following broad classifications: (a) Electronics Equipment; (b) Implants; (c) Consumables and Disposables; (d) IVD reagents; and (e) Surgical Instruments.
Salient features of National Policy for the Medical Devices, 2022
- Regulatory streamlining in order to optimize regulatory processes and multiplicity of agencies for enhanced ease of doing business, along with harmonization with global standards to ensure standardization.
- Quality Standards and Safety of the Devices in order to provide safe devices to the consumers, in harmony with the global standards.
- Building Competitiveness through fiscal and financial support for stimulating the development of the local manufacturing ecosystem with private sector investments.
- Infrastructure Development to provide best-in-class physical foundation, including medical devices parks with common facilities such as testing centres, to improve cost competitiveness and enhance attraction of domestic manufacturers.
- Facilitating R&D and Innovation with a focus on enhanced collaboration in innovation and R&D projects, global partnerships, and joint ventures among key stakeholders to bridge the gap between academic curriculum and industry requirements.
- Human Resource Development to ensure relevant curriculum at higher education level, skilling of various stakeholders, creation of future-ready HR with required skill sets across the innovation value chain.
- Awareness Creation and Brand Positioning in creating awareness and positioning India as a hub for manufacturing of medical devices as part of the “Make in India, Make for the World” initiative.
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