India Medical Device Regulations

Log into RAMS to download the documents listed below along with more regulations and guidances for India.

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

Questions? Request more information from our specialists

CONTACT US