New Delhi, Oct 3 The Central Drugs Standard Control Organization, under the Ministry of Health and Family Welfare, has become an affiliate member of the International Medical Device Regulators Forum (IMDRF), the ministry announced on Thursday.
IMDRF is a global network of medical device regulators that promotes regulatory convergence and public health and safety.
The CDSCO had applied for the IMDRF membership in August to achieve global alignment in its medical device regulatory system. The regulator received the approval during the 26th Session of IMDRF held in September in Washington, US.
“Achieving affiliate membership in the IMDRF will provide significant opportunities for reliance and collaboration with regulatory authorities around the world,” the ministry said, adding it will strengthen the "Brand India" in the global market.
Currently, IMDRF members include national regulatory authorities from the US, Australia, Canada, the European Union, Japan, the UK, Brazil, Russia, China, South Korea, Singapore, and the World Health Organization (WHO).
To align with the global standards, the Health Ministry on Thursday also introduced comprehensive regulations for medical devices.
The initiative is aimed at aligning the country's regulatory framework with globally accepted standards, and seeks to foster a regulatory ecosystem that promotes growth and innovation in the medical device sector.
Further, the IMDRF membership will also help to harmonise regulatory requirements across the globe, which reduces the complexity for manufacturers and helps safeguard public health by promoting collaboration, harmonising regulations, and promoting convergence.
The membership also helps to support innovation and timely access to new medical devices.
The ministry said that “as an affiliate member, India will participate in IMDRF Open Sessions to have information exchange on technical topics with other regulators”.
The discussions will range from the latest medical device regulatory strategies and trends to providing feedback on India’s experience and perspectives and using IMDRF documents in part or in whole as the basis for India’s regulatory framework for medical devices.
The membership will “strengthen the CDSCO’s medical device regulatory system, helping meet emerging technical challenges that are increasingly diverse, to ensure the protection of public health and safety, and continue to maintain the goal of international recognition for its medical device regulation”, the ministry said.
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