National Medical Devices Policy, 2023 Approved by Union Cabinet

National Medical Devices Policy 2023 is focused on prioritizing patient needs and accelerating growth in the medical devices sector to keep pace with changing healthcare requirements.

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National Medical Devices Policy: it is a policy formulated by the government to support and strengthen medical devices industry in India to become more competitive, self-sufficient, robust, and inventive in this sector. National Medical Devices Policy 2023 is also important for UPSC Prelims Exam 2023 and UPSC Mains Exam (GS Paper 2- Various government Policies and Programs for development of various sectors).

National Medical Devices Policy, 2023 in News

Recently, Union Cabinet, chaired by the Hon’ble Prime Minister Shri Narendra Modi, approved the National Medical Devices Policy, 2023.

National Medical Devices Policy Details

The National Medical Devices Policy, 2023 is aimed at bolstering the medical devices industry in India to become more competitive, self-sufficient, robust, and inventive in order to meet the healthcare demands of both India and the rest of the world.

Focus Area: The National Medical Devices Policy is focused on prioritizing patient needs and accelerating growth in the medical devices sector to keep pace with changing healthcare requirements.
Vision:Accelerated growth path with a patient-centric approach and to emerge as the global leader in the manufacturing and innovation of medical devices by achieving 10-12% share in the expanding global market over the next 25 years.
- Policy is expected to help the Medical Devices Sector grow from present $11 Bn to $50 Bn by 2030.
Mission:Policy lays down a roadmap for accelerated growth of the medical devices sector to achieve the following missions viz, Access & Universality, Affordability, Quality, Patient Centred & Quality Care, Preventive & Promotive Health, Security, Research and Innovation and Skilled manpower.

Salient Features of National Medical Devices Policy, 2023

Medical devices sector will be facilitated and guided through a set of strategies that will be cover six broad areas of policy interventions:

Regulatory Streamlining

In order to enhance ease of doing research and business and further to balance patient safety with product innovation measures such as creation of a Single Window Clearance System’ for Licensing of Medical Devices coopting all the stakeholder departments / organizations such as AERB, MeitY, DAHD, etc, enhancing the Role of Indian Standards like BIS and designing a coherent pricing regulation, will be followed.

Enabling Infrastructure

The establishment and strengthening of large medical device parks, clusters equipped with world class common infrastructure facilities in proximity to economic zones with requisite logistics connectivity as envisioned under the National Industrial Corridor Program and the proposed National Logistics Policy 2021 under the ambit of PM Gati Shakti, would be pursued with the State Governments and Industry for better convergence and backward integration with medical device Industry

Facilitating R&D and Innovation

The policy envisages to promote Research & Development in India and complement the Department’s proposed National Policy on R&D and Innovation in the Pharma- MedTech Sector in India. It also aims at establishing Centres of Excellence in academic and research institutions, innovation hubs, ‘plug and play’ infrastructures and support to start-ups.

Attracting Investments in the Sector

Along with resent schemes and interventions like Make in India, Ayushman Bharat program, Heal-in-India, Start-up mission, the policy encourages private investments, series of funding from Venture Capitalists, and also Public-Private Partnership(PPP).

Human Resources Development

In order to have a steady supply of skilled work force across the value chain such as scientists, regulators, health experts, managers, technicians, etc., the policy envisages:

For skilling, reskilling and upskilling of professionals in the medical device sector, we can leverage the available resources in Ministry of Skill Development and Entrepreneurship
The policy will support dedicated multidisciplinary courses for medical devices in existing institutions to ensure availability of skilled manpower for futuristic medical technologies, high-end manufacturing and research, to produce future-ready MedTech human resources and to meet the evolving needs of the Sector
To develop partnerships with foreign academic/industry organizations to develop medical technologies in order to be in equal pace with the world market.

Brand Positioning and Awareness Creation

The policy envisages the creation of a dedicated Export Promotion Council for the sector under the Department which will be an enabler to deal with various market access issues:

Initiate studies and projects for learning from best global practices of manufacturing and skilling system so as to explore the feasibility of adapting such successful models in India.
Promote more forums to bring together various stakeholders for sharing knowledge and build strong networks across the sector.

National Medical Devices Policy for Medical Device Industry

The National Medical Devices Policy for 2023 is set to promote the systematic expansion of the medical device industry in order to address the public health goals of accessibility, affordability, quality, and innovation.

The sector is expected to reach its full potential by implementing several strategies, such as establishing a favorable ecosystem for manufacturing and innovation, developing a strong and efficient regulatory framework, providing support for training and capacity building initiatives, and encouraging higher education to cultivate skilled and talented professionals that align with the industry’s needs.
The encouragement of domestic investments and local production of medical devices is consistent with the Indian Government’s “Atmanirbhar Bharat” and “Make in India” initiatives.

National Medical Devices Policy Significance

There is a pressing need for a comprehensive policy framework to accelerate the growth and maximize the potential of the medical device sector. Although various government departments have implemented programs to promote the sector, the National Medical Devices Policy 2023 seeks to establish a cohesive set of growth focus areas in a coordinated manner.

Additionally, due to the diverse and interdisciplinary nature of the industry, regulations, skilling initiatives, and trade promotion efforts for the medical device industry are scattered across multiple government departments at both the central and state levels.
Therefore, it is essential to bring together these interventions in a coherent manner to provide efficient and focused support and facilitation for the sector by the relevant agencies.

Medical Devices Park Scheme

National Medical Commission Act

FAQs

What is the National Medical Devices Policy?

The National Medical Devices Policy is a policy framework developed by the Indian government to support and strengthen the medical devices industry in India. The policy aims to make the industry more competitive, self-reliant, resilient and innovative to cater to the healthcare needs of not only India but also the world.

When was the National Medical Devices Policy announced?

The National Medical Devices Policy was announced in April 2023.

What are the key objectives of the National Medical Devices Policy?

The key objectives of the National Medical Devices Policy include promoting research and development in the medical devices sector, encouraging domestic manufacturing of medical devices, improving access to affordable medical devices, and enhancing the regulatory framework for medical devices.

How does the National Medical Devices Policy plan to achieve its objectives?

The National Medical Devices Policy plans to achieve its objectives by providing financial support for research and development in the medical devices sector, setting up medical device parks, providing incentives for domestic manufacturing, streamlining regulatory processes, and creating a favorable environment for innovation and entrepreneurship in the medical devices industry.