
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 |