Draft National Policy for the Medical Devices, 2022

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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