Healthcare, Industry News, Medical Devices, Regulatory Affairs

Ministry of Health and Family Welfare, India propose use of American Standard Test Methods for medical device conformance

India’s Ministry of Health and Family Welfare has proposed recognizing American Standard Test Methods (ASTM) as acceptable tools for demonstrating conformance of medical devices to safety and conformance requirements and obtaining market access in the country.

The notification would amend India’s Medical Device Rules, 2017 to allow medical device market applicants to use ASTM methods to demonstrate conformance; current regulations in India recognize ISO and IEC international medical device standards only. Recognizing ASTM would provide manufacturers with another option for demonstrating conformance as part of their device registration with the Central Drugs Standard Control Organization (CDSCO).

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