Draft National Medical Devices Policy 2022
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Context: Ministry of Chemicals and Fertilizers released 'Draft National Medical Devices Policy 2022'.
Details:
- The Department of Pharmaceuticals, under the Ministry of Chemicals and Fertilizers has released the Draft National Policy for the Medical Devices, 2022 on its website for consultation.
- The Department has invited feedback and remarks of the Industry and stakeholders, till the 25th March.
Objectives of the Draft Policy:
- The Ministry of Chemicals and Fertilizers said that the Draft policy aims at addressing the core objectives of accessibility, affordability, safety and quality, focus on self-sustainability, innovation and growth in the Medical devices sector.
- Regulatory streamlining to optimize regulatory processes and to promote ease of doing business.
- Quality Standards and Safety of the Devices in order to provide safe devices to the consumers.
- Infrastructure Development to provide the best physical foundation, including medical devices parks with common facilities such as testing centers, to improve cost competitiveness and enhance attraction of domestic manufacturers.
- Promoting Research and Development and Innovation.
- Human Resource Development to create manpower with required skills.
- 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.
- This Policy target that by 2047, our Country
- Will be home and originator to 25 high-end futuristic technologies in MedTech.
- Will have a MedTech Industry of $100-300 Bn size with 10-12% of Global Market Share.
Significance of the Medical Device Sector in India:
- The medical devices sector in India is an essential and integral constituent of the Indian healthcare sector, particularly for the prevention, diagnosis, treatment and management of all medical conditions, diseases, illnesses, and disabilities.
- The Sector is expected to grow in market size from the present 11 billion US dollar to 50 billion US dollar by 2025.
- The medical device is a multi-product sector, with the following broad classifications:
- Electronics Equipment
- Implants
- Consumables and Disposables
- Surgical Instruments.
- The Indian medical devices sector’s contribution has become even more prominent as India supported the global battle against COVID-19 pandemic through the production of medical devices and diagnostic kits, e.g., Ventilators, RT-PCR kits, IR Thermometers, PPE Kits & N-95 masks.
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