India is now an affiliate member of the International Medical Device Regulators Forum as a part to strengthen international collaboration in regulating medical devices and technologies, hence opening the doors for “wonderful avenues of cooperation and reliance on international regulatory bodies,” penned the Union Health Ministry in a statement.
IMDRF stands for International Medical Device Regulators Forum, founded in 2011 with the vision of providing better global harmonization of medical device regulations. The core mission of the organization is to get stakeholders aligned around regulatory standards that protect patient safety and also allow access to new technologies by building on their availability.
The current membership of the IMDRF comprises the representatives of regulatory authorities from the world’s key players, which include the World Health Organization (WHO), Singapore, America, South Korea, Australia, Russia, Canada, China, United Kingdom, Brazil, Japan and the European Union.
The Central Drugs Standard Control Organization, an arm of the Ministry of Health and Family Welfare in India, has led the country’s application to become an affiliate member. This step keeps in line with India’s objectives of rationalizing its medical device regulatory system, making its domestic industry more competitive, and enhancing its international presence in the sphere of healthcare innovations.
It would mean closer proximity to the international standards while India sits as an affiliate member in IFSMA and means increased cooperation and better access to international markets for this entire medical device industry.
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