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 imposed the Medical Device Rules in January 2018; regulatory and guidance documents referring to its requirements are available here.

Major Regulations

Cosmetics Regulation in Indiaen Part II, Section 3(i)3/2010
India Medical Devices Rules 2017en N/A01/2017

General Guidance Documents

Guidance - Device/IVD Classification under the Medical Device Rules, 2017en 29/Misc./3/2017-DC(292)05/2019
Guidance - Grouping Guidelines for Medical Devices Applicationsen N/A03/2018

Additional Information

IVDs - Frequently Asked Questionsen en en N/A02/2017