India Medical Device Regulations

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Major Regulations
Document Number Published Language
Log in India Medical Devices Rules, 2017 N/A 01/2017 English
General Guidance Documents
Document Number Published Language
Log in Essential Principles for Safety and Performance of Medical Devices Guidelines 2018 English
Log in Grouping Guidelines for Medical Devices 03/2018 English
Log in Notice on Classification of Medical Devices 29/Misc./3/2017-DC(292) 05/2019 English
Specific Guidance Documents
Document Number Published Language
Log in Gazette Notification G.S.R. 102(E) 102(E) 2020 English
Log in Gazette Notification S.O. 648(E) 648(E) 2020 English
Log in Gazette Notification S.O. 775(E) 775(E) 2019 English
Log in Guidance on Performance Evaluation of In-Vitro Diagnostic Medical Devices N/A 2018 English
Additional Information
Document Number Published Language
Log in Grouping Guidelines - Frequently Asked Questions N/A English