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

Cosmetics Regulation in Indiaen Part II, Section 3(i)3/2010
India Medical Devices Rules 2017en 001/2017

General Guidance Documents

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
Guidance - Device/IVD Classification under the Medical Device Rules, 2017en 29/Misc./3/2017-DC(292)11/2017
India Specific Labeling and Universal Packingen No. 443/2014

Specific Guidance Documents

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

Additional Information

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