India joins global medical device regulator, IMDRF as affiliate member
- In Reports
- 05:29 PM, Oct 03, 2024
- Myind Staff
India has joined the International Medical Device Regulators Forum as an affiliate member. This move will create valuable opportunities for reliance and collaboration with regulatory authorities around the world, according to a statement from the Union Health Ministry on Thursday.
The International Medical Device Regulation Forum (IMDRF) is a coalition of international medical device regulators that was founded in 2011 with the goal of expediting the adoption of international medical device regulatory convergence and harmonisation. The World Health Organisation (WHO) and national regulatory agencies from the US, Australia, Canada, the European Union, Japan, the UK, Brazil, Russia, China, South Korea, and Singapore are among its members.
"To achieve global alignment in its medical device regulatory system, enhance the competitiveness of the domestic industry and boost transnational prominence, the Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, applied for Affiliate Membership in the International Medical Device Regulators Forum (IMDRF) in 2024," said the statement issued by the Health Ministry.
"After review of India's application for affiliate membership and meeting discussions by the IMDRF Management Committee (MC) with the senior officers of CDSCO during the 26th Session of IMDRF held in September 2024 at Seattle, Washington, USA, the CDSCO has received approval from IMDRF as an affiliate member of the forum," it added. According to the statement, becoming an affiliate member of the IMDRF will provide access to priceless chances for trust and cooperation with regulatory bodies around the globe.
By encouraging cooperation, harmonising laws, and fostering convergence, membership contributes to the global harmonisation of regulatory requirements, which lessens complexity for manufacturers and protects public health. As an affiliate member, India will take part in IMDRF open sessions to share technical information with other regulators, talk about the newest approaches and developments in medical device regulation, offer input on its experiences and viewpoints, and use portions or all of the IMDRF documents as the foundation for its own medical device regulatory framework.
This will fortify the CDSCO's medical device regulatory framework, supporting it in addressing new and varied technological challenges, safeguarding public health and safety, and advancing the organisation's objective of achieving worldwide recognition for its medical device regulation, according to the statement.
Additionally, this membership will also make it possible for Indian producers of medical devices to comply with the legal requirements of IMDRF member nations, enhancing "Brand India" internationally.
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