India Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for India.
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | India Medical Devices Rules, 2017 | N/A | 01/2017 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Essential Principles for Safety and Performance of Medical Devices Guidelines | 2018 | English | |
| Log in | Grouping Guidelines for Medical Devices | 03/2018 | English | |
| Log in | Notice on Classification of Medical Devices | 29/Misc./3/2017-DC(292) | 05/2019 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Gazette Notification G.S.R. 102(E) | 102(E) | 2020 | English |
| Log in | Gazette Notification S.O. 648(E) | 648(E) | 2020 | English |
| Log in | Gazette Notification S.O. 775(E) | 775(E) | 2019 | English |
| Log in | Guidance on Performance Evaluation of In-Vitro Diagnostic Medical Devices | N/A | 2018 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Grouping Guidelines - Frequently Asked Questions | N/A | English |
