India Medical Device Regulations

All documents listed below were published by the Ministry of Health and Family Welfare (MHFW) and are in PDF format. The Ministry of Health and Family Welfare is currently in the process of imposing more regulations on a broader range of devices. As more documents become available, we will post them here. 

Major Regulations

DocumentLanguageNumberPublished
Cosmetics Regulation in Indiaen Part II, Section 3(i)3/2010
Draft Medical Device Rules 2016en Draft2016
Drugs and Cosmetics Acten No. 231940
Notification of draft rules introducing Schedule M-III for medical devices and IVDsen G.S.R. 357(E).03/2016

General Guidance Documents

DocumentLanguageNumberPublished
Clarification to the List of Notified Medical Devicesen 29/Misc./3/2009-DC03/2012
Guidance - Common Submission Format for Registration/Re-Registrationen MD/GD/RC/01/0010/2012
India Specific Labeling and Universal Packingen No. 443/2014

Specific Guidance Documents

DocumentLanguageNumberPublished
Clarification On Import And Manufacture Of Medical Devicesen N/A--

Additional Information

DocumentLanguageNumberPublished
List of Notified Medical Devices (List of Gazetted Devices)en N/A11/2014