In the notification published on 5 February 2021 in the Official Gazette, the India’s Ministry of Health and Family Welfare (MoHFW) proposed to recognise methods and standards of the American Society for Testing and Materials International (ASTM International) to access the compliance of Medical Devices with safety requirements, in order to facilitate the entry of devices on the Indian market.
What are the American Standard Test Methods (ASTM)?
The American Society for Testing and Materials International is a US standardization body recognized worldwide for the development and supply of international standards. ASTM methods and standards are used to improve product quality, increase and ensure security, facilitate access to trade and markets.
There are several ASTM standards for Medical Devices.
Are there any changes to the Medical Devices Rules?
The notification published by the India’s Ministry of Health and Family Welfare could make changes to the Medical Devices Rules Indian Regulation, in order to allow companies in the field of Medical Devices to use ASTM standards to demonstrate the conformity of the products. At the moment, indeed, the regulation in force in India recognizes only the international ISO and IEC device standards.
If the Ministry’s proposal to recognize the American Standard Test Methods (ASTM) will be taken into account and accepted, Manufacturers will have these standards at their disposal to demonstrate the conformity of their Medical Devices during the registration process at the Central Drugs Standard Control Organization (CDSCO) which is the Indian Regulatory Authority for pharmaceutical products and Medical Devices.
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