
Ministry of Health and Family Welfare (MOH&FW) notified the Medical Devices Rules 2017 on 31.01.2017 under the provisions of the Drugs and Cosmetics Act, 1940. The MDR 2017 are effective from 01.01.2018 to regulate the Clinical Investigation, Manufacture, Import, Sale and Distribution of the medical devices in the country. These rules are harmonized with the international regulatory practices and provide comprehensive legislation for the regulation of Medical Devices fostering Make in India as well.
The medical device rules were formulated with the aim to standardize and regulate medical devices. The new Rules were framed in conformity with Global Harmonization Task Force (GHTF) framework and conform to best international practices. Products which fall under the classification criteria as per Medical Device Rules, 2017 would be now regulated and assigned a class based on associated risk.
Classification Medical Device in India (Medical Device Regulation MDR 2017)
Introduction to Indian Medical Device Rules 2017
What is MDR2017 ??
What is Medical Device Classification as per MDR 2017
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