List of Notified and Non Notified Medical Devices released by CDSCO
List of Notified Medical Devices & IVDs
CDSCO has published list of Notified Medical Devices & IVDs through series of notifications over the last few years.
List of Newly Notified Medical Devices and IVDs published by CDSCO on 15th May 2019 is shared below for quick reference :
All subsequent amendments to the above list of Notified Med Devices and IVDs, comprising of 37 devices / IVDs / group of products, is available here for a ready reference :
List of Non Notified IVDs
CDSCO has published list of Non Notified IVDs comprising of IVD Analyers, IVD Instruments, IVD Software and the same can be downloaded from here :
List of Non Notified Medical Devices
Since Medical Devices are brought under full regulation wef 1st of April 2020 in the country, CDSCO has been publishing the Classification of Non Notified Devices under various categories and the complete List of classified Non Notified Devices is listed below :
| Srl No | Category | Release Date | Document Link |
| 1 | Classification of Medical Device pertaining to Oncology under the provisions of Medical Devices Rules, 2017 | 2022-Oct-11 | https://bit.ly/3TbeaOb |
| 2 | Classification of Medical Device Pertaining to Dental Under the provision of Medical Devices Rules 2017 | 2022-Oct-10 | https://bit.ly/3EQ7Bwl |
| 3 | Classification of Medical Device Pertaining to non-sterile, non-powered, hand-held or hand-manipulated Surgical Instruments for general use intended to be used in various general surgical procedures | 2022-Sep-09 | https://bit.ly/3eXsyKN |
| 4 | Classification of Medical Device Pertaining to Rehabilitation under the Provisions of Medical Devices Rules 2017 | 2022-Aug-04 | https://bit.ly/3xyiRZL |
| 5 | Classification of Medical Device Pertaining to Obstetrical and Gynecological Under the provision of Medical Devices Rules 2017 | 2022-Jun-03 | https://bit.ly/3qOGwkR |
| 6 | Classification of Medical Device Pertaining to Dental Under the provision of Medical Devices Rules 2017 | 2022-Jun-03 | https://bit.ly/3SaZ3TZ |
| 7 | Classification of Medical Device pertaining to General Hospital under the provisions of Medical Devices Rules 2017 | 2022-Mar-16 | https://bit.ly/3QQBE9p |
| 8 | Classification of Medical Device pertaining to General Hospital / Orthopaedic Instrument under the provisions of Medical Devices Rules, 2017 | 2022-Feb-23 | https://bit.ly/3Mm3rgK |
| 9 | Classification of Medical Device pertaining to Neurological under the provisions of Medical Devices Rules, 2017 | 2021-Sep-28 | https://bit.ly/3odhBr5 |
| 10 | Classification of Medical Device pertaining to Oncology under the provisions of Medical Devices Rules, 2017 | 2021-Sep-27 | https://bit.ly/3ARDuzs |
| 11 | Classification of Medical Device pertaining to Gastroenterology under the provisions of Medical Devices Rules, 2017 | 2021-Sep-27 | https://bit.ly/39KWFiA |
| 12 | Classification of Medical Device pertaining to General Hospital under the provisions of Medical Devices Rules 2017 | 2021-Sep-13 | https://bit.ly/3hKMLlu |
| 13 | Classification of Medical Device pertaining to Pain Management under the provisions of Medical Devices Rules 2017 | 2021-Sep-13 | https://bit.ly/3nLR2sM |
| 14 | Classification of Medical Device pertaining to Nephrology and Renal Care under the provisions of Medical Devices Rules 2017 | 2021-Sep-13 | https://bit.ly/3zplD1m |
| 15 | Classification of Medical Device pertaining to Personal Protective Equipment under the provisions of Medical Devices Rules 2017 | 2021-Sep-13 | https://bit.ly/3Asfxyy |
| 16 | Classification of Medical Device pertaining to Software under the provisions of Medical Devices Rules 2017 | 2021-Sep-13 | https://bit.ly/3lJn5a0 |
| 17 | Classification of Medical Device pertaining to Operation Theatre under the provisions of Medical Devices Rules 2017 | 2021-Sep-13 | https://bit.ly/3CqH83S |
| 18 | Classification of Medical Device Pertaining to Dental Under the provision of Medical Devices Rules 2017 | 2021-Aug-23 | https://bit.ly/3A3TCh7 |
| 17 | Classification of Medical Device Pertaining to Urology Under the provision of Medical Devices Rules 2017 | 2021-Aug-23 | https://bit.ly/3k0zEy4 |
| 19 | Classification of Medical Device Pertaining to Pediatrics and Neonatology Under the provision of Medical Devices Rules 2017 | 2021-Aug-23 | https://bit.ly/3leontB |
| 20 | Classification of Medical Device Pertaining to Obstetrical and Gynecological Under the provision of Medical Devices Rules 2017 | 2021-Aug-23 | https://bit.ly/3E93nNl |
| 21 | Classification of Medical Devices Pertaining to Ophthalmology under the Provisions of Medical Devices Rules 2017 | 2021-Aug-09 | https://bit.ly/3C3msyQ |
| 22 | Classification of Medical Device Pertaining to Radiotherapy under the Provisions of Medical Devices Rules 2017 | 2021-Aug-06 | https://bit.ly/3yXldiA |
| 23 | Classification of Medical Device Pertaining to Respiratory Under the Provisions of Medical Devices Rules 2017 | 2021-Aug-06 | https://bit.ly/3E65odh |
| 24 | Classification of Medical Devices Pertaining to ENT under the Provisions of Medical Devices Rules 2017 | 2021-Aug-06 | https://bit.ly/3A493Wy |
| 25 | Classification of Medical Device Pertaining to Interventional Radiology under the Provisions of Medical Devices Rules 2017 | 2021-Jul-26 | https://bit.ly/38YynBp |
| 26 | Classification of Medical Device Pertaining to Dermatological and Plastic Surgery under the Provisions of Medical Devcies Rules 2017 | 2021-Jul-26 | https://bit.ly/38YjpeB |
| 27 | Classification of Medical Device Pertaining to Physical Support under the Provisions of Medical Devices Rules 2017 | 2021-Jul-26 | https://bit.ly/3npybDt |
| 28 | Classification of medical device pertaining to Cardiovascular under the provisions of Medical Devices Rules 2017 | 2021-Jul-26 | https://bit.ly/3jYqD8O |
| 29 | Classification of Medical Device Pertaining to Rehabilitation under the Provisions of Medical Devices Rules 2017 | 2021-Jul-26 | https://bit.ly/3A5KfNM |
| 30 | Classification of medical devices pertaining of Anesthesiology under the provision of Medical Devices Rules 2017 | 2021-Jul-12 | https://bit.ly/3Ebc49R |
Note : Some product categories listing is updated by CDSCO regularly and hence fresh notifications are released with amended/upgraded list under few categories.
All Notified Devices are under compulsory licensing and all non notified devices are under mandatory registration till October 2022 for Class A & B Devices and till October 2023 for Class C & D Devices. There after , all come under compulsory licensing process.