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
| Document | Language | Number | Published |
|---|---|---|---|
| Cosmetics Regulation in India | en | Part II, Section 3(i) | 3/2010 |
| India Medical Devices Rules 2017 | en | N/A | 01/2017 |
General Guidance Documents
| Document | Language | Number | Published |
|---|---|---|---|
| Guidance - Device/IVD Classification under the Medical Device Rules, 2017 | en | 29/Misc./3/2017-DC(292) | 05/2019 |
| Guidance - Grouping Guidelines for Medical Devices Applications | en | N/A | 03/2018 |
Additional Information
| Document | Language | Number | Published |
|---|---|---|---|
| IVDs - Frequently Asked Questions | en en en | N/A | 02/2017 |