Last Updated on January 6, 2024 by The Health Master
Advancing the National Medical Devices Policy
Download National Medical Devices Policy, 2023, the link is given below. In May 2023, the Department of Pharmaceuticals (DoP), Govt of India took significant steps towards implementing the National Medical Devices Policy, 2023.
To ensure the successful execution of this policy, the DoP has released an elaborate strategy document.
This document highlights crucial aspects such as data security measures, the adoption of national nomenclature for medical devices, e-waste management, and the strengthening of technology transfer capabilities within the medical devices sector.
Data Security Measures:
The strategy document acknowledges the growing influence of digital technology in healthcare and the consequent need for robust data security measures.
It outlines the government’s intention to align regulations concerning the medical devices sector with national laws for personal health data security.
The document emphasizes the implementation of suitable mechanisms for data security and data annotation to ensure patient data safety.
Adoption of National Nomenclature for Medical Devices:
The DoP aims to promote the adoption of a National Nomenclature for Medical Devices in collaboration with the Central Drugs Standard Control Organization (CDSCO) and the Department of Health and Family Welfare.
As part of regulatory streamlining efforts, the DoP plans to advocate the use of either the Global Medical Devices Nomenclature (GMDN) or the Universal Medical Device Nomenclature System (UMDNS).
The document also highlights the development of guidelines under the Standard Setting Organization, such as the Bureau of Indian Standards, to assist researchers, innovators, and entrepreneurs throughout the research, design, and testing phases of product development.
Enhancing Innovation and Research:
To facilitate innovation and research, the DoP intends to create awareness among the innovation community regarding regulatory compliance at the early stages of product development.
This will be achieved through structured programs, including curriculum courses, skill training, and workshops.
Strengthening technology transfer capabilities is another focus area, which will enable academia to effectively translate knowledge into products and technologies.
Leveraging technology transfer offices, such as DBT-BIRAC and AGNIi, will support the transfer of technology and promote academic patenting.
Intellectual Property Development and Commercialization:
The strategy document emphasizes collaboration with the Department for Promotion of Industry and Internal Trade (DPIIT) to incentivize innovation in the medical devices field.
By incentivizing both institutions and inventors, the aim is to foster a robust technology transfer ecosystem within India and maximize the utilization of government-funded inventions.
The focus will be on developing innovative products that generate new intellectual property and disrupt the field.
Additionally, a mechanism will be established to guide innovators and intellectual property holders towards successful commercialization of their products.
Attracting Investments and Human Resource Development:
To attract investments in the medical devices sector, the strategy document proposes fiscal and non-fiscal measures.
These measures include providing incubation support for start-ups in research and development, mentorship programs for entrepreneurs, skill development in business management, market access facilitation, commercialization efforts, and technology transfer mechanisms for innovative solutions.
Furthermore, in order to bridge the gap in design expertise, the document highlights the encouragement of National Institutes of Design (NID) and private design schools to offer design-centric courses.
Conclusion:
The release of the comprehensive strategy document by the Department of Pharmaceuticals, Govt of India marks a significant step towards advancing the National Medical Devices Policy, 2023.
By addressing critical aspects such as data security, national nomenclature adoption, e-waste management, and technology transfer capabilities, the document outlines a clear roadmap for the development and growth of the medical devices sector in India.
Through collaborative efforts and a focus on innovation, this strategy aims to position India as a global leader in the field of medical technology.
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