Indian Medical devices regulation basics
Here below are reported some of the most relevant guidance for Medical Device Registration in Indian market:
Major Regulations
| Regulation | Year |
| Cosmetics Regulation in India | 2010 |
| India Medical Devices Rules | 2017 |
General Guidance Documents
| Document | Year |
| Guidance – Device/IVD Classification under the Medical Device Rules of 2017 | 2019 |
| Guidance – Grouping Guidelines for Medical Devices Applications | 2018 |
Additional Information
| Document | Year |
| Frequently Asked Questions –grouping guidelines –IVDs –medical devices | 2017 |