Becoming an affiliate member of IMDRF will open doors to invaluable opportunities.
India has become an affiliate member of the International Forum of Medical Device Regulators, which will open doors to invaluable opportunities for trust and collaboration with regulatory authorities across the world, the Union Health Ministry said on Thursday.
The IMDRF, which was established in 2011, is a group of global medical device regulators whose goal is to accelerate the adoption of international medical device regulatory harmonization and convergence.
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Its members include national regulatory authorities from the US, Australia, Canada, the European Union, Japan, the United Kingdom, Brazil, Russia, China, South Korea, Singapore and the World Health Organization (WHO).
“To achieve global alignment in its medical device regulatory system, enhance domestic industry competitiveness and boost transnational prominence, the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, requested to be an Affiliate Member in the International Association of Medical Device Regulators Forum (IMDRF) in 2024,” the Ministry of Health said in a statement.
“Following the review of India’s affiliate membership application and discussions of the IMDRF Management Committee (MC) meeting with CDSCO senior officials during the 26th IMDRF session held in September 2024 in Seattle, Washington, USA, CDSCO received approval from IMDRF as an affiliate member of the forum,” he said.
Becoming an affiliate member of the IMDRF will open doors to invaluable opportunities for trust and collaboration with regulatory authorities around the world, he said.
Membership helps harmonize regulatory requirements around the world, reducing complexities for manufacturers and helping to safeguard public health by promoting collaboration, harmonizing regulations and promoting convergence.
As an affiliate member, India will participate in IMDRF open sessions for information exchange on technical topics with other regulators, to discuss the latest medical device regulatory strategies and trends, provide feedback on its experience and perspectives and use IMDRF documents in part or in its entirety as the basis of its regulatory framework for medical devices.
This will strengthen CDSCO’s medical device regulatory system, helping to address emerging technical challenges that are increasingly diverse, ensuring the protection of public health and safety, and continuing to maintain the goal of international recognition for its medical device regulation, according to the statement.
This membership will also enable Indian medical device manufacturers to meet the regulatory requirements of IMDRF member countries, thereby strengthening ‘Brand India’ in the global market, it said.
(Only the title and image of this report may have been modified by Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
First published: October 3, 2024 | 15:42 IS
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