National Medical Devices Policy, 2023

• 02 May 2023

On April 26, 2023, the Indian government approved the National Medical Devices Policy, 2023.

Aims: It aims to place the medical devices sector on an accelerated path of growth with a patient-centric approach to meet the evolving healthcare needs of patients.

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.

Objective: Policy is expected to help the medical devices sector grow from present $11 billion to $50 billion by 2030.

Key Features

• Enabling Ecosystem for Manufacturing and Innovation: Promote the development of a robust medical device industry in India, including promoting innovation and research and development.
• Ensuring Quality and Safety: Ensure that medical devices manufactured and sold in India meet high-quality standards and are safe for patients and users.
• Facilitating Business: Facilitate the ease of doing business in the medical device sector, including simplifying regulatory processes and encouraging investment in the sector.
• Localization of Manufacturing: Encourage the localization of medical device manufacturing to reduce India's dependence on imports.
• Improve Access to Affordable Medical Devices: Increase access to affordable medical devices for patients and healthcare providers in India, especially in rural areas.
• Foster Adoption of Innovative Technologies and Digital Solution: Promote the use of technology and digital solutions in the medical device sector to improve patient outcomes and healthcare delivery.
• Establishing a Strong Regulatory Framework: Establish a strong regulatory framework for medical devices that is aligned with international best practices and standards.
• Encouraging Collaboration for Innovation and Healthcare Outcomes: Encourage collaboration between industry, academia, and healthcare providers to promote innovation and improve healthcare outcomes in India.