The Department of Pharmaceuticals has released \u201cDraft National Policy for the Medical Devices, 2022\u201d.<\/span><\/p>\n 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.\u00a0<\/span><\/p>\n The Medical Device Sector has remained largely unregulated till 2017 when Medical Device Rules,2017 were framed by CDSCO<\/a> for comprehensive regulation of Medical Devices in a phased manner especially on the quality, safety, and efficacy aspects, under the Drugs and Cosmetic Act, 1940.<\/p>\n The Indian medical device market has a significant presence of multinational companies with about 80% of the sales by value generated from imported medical devices.<\/p>\n This Sector is expected to grow in market size from the present $11 Bn to $50 Bn by 2025.<\/span><\/p>\n Moreover, to encourage the domestic manufacturing of Medical Devices, Government has launched PLI scheme for promoting domestic manufacturing of Medical Devices, Promotion of Medical Devices Parks.<\/em><\/strong><\/a><\/p>\n Released by: <\/b>Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers.<\/span><\/p>\n Aim: <\/b>To address core objectives of accessibility, affordability, safety and quality, focus on self-sustainability, innovation and growth in the Medical devices sector.<\/span><\/p>\n Objectives:<\/b> The <\/span>policy envisions that by 2047, India<\/span><\/p>\n \u2013 Will be having few National Institutes of Medical Devices Education and Research (NIMERs) on the lines of NIPERs<\/a>;<\/span><\/p>\n \u2013 Will be home & originator to 25 high-end futuristic technologies in MedTech<\/span><\/p>\n \u2013 Will have a MedTech Industry of $100-300 Bn size with 10-12% of Global Market Share.<\/span><\/p>\n – Regulatory streamlining\u00a0<\/strong>in order to optimise regulatory processes and multiplicity of agencies for enhanced ease of doing business.<\/p>\n – Quality Standards and Safety of the Devices\u00a0<\/strong>in order to provide safe devices to the consumers.<\/p>\n – Building Competitiveness through fiscal and financial support<\/strong>.<\/p>\n – Infrastructure Development\u00a0<\/strong>to provide a best-in-class physical foundation, including medical devices parks.<\/p>\n – Facilitating R&D and Innovation\u00a0<\/strong>with a focus on enhanced collaboration in innovation and R&D projects.<\/p>\n – Awareness Creation and Brand Positioning\u00a0<\/strong>in creating awareness and positioning India as a hub for manufacturing of medical devices as part of the \u201cMake in India, Make for the World\u201d initiative.<\/p>\nWhat is the Medical Devices Sector?<\/b><\/h5>\n
What is the Draft National Policy for the Medical Devices, 2022?<\/b><\/h5>\n
Features of the Policy<\/strong><\/h5>\n