Russia medical device registration
Outline for Russia medical device registration
To export medical device to Russia, Registration Certificate must be achieved in Federal service on surveilance in healthcare /ROSZDRAVNADZOR).
Medical device registration procedure
| Stage | Procedure | Charge |
|---|---|---|
| 1 | Technology and toxicology test | Laboratory in Russia |
| 2 | Technology and toxicology test report and other essential information submission | ROSZDRAVNADZOR |
| 3 | Check registration status of essential document for submission | |
| 4 | Primary inspection and supplementation request | |
| 5 | Supplementary information submission | Manufacturer |
| 6 | Evaluation of supplementary information and decision on possibility of clinical assessment | ROSZDRAVNADZOR |
| 7 | Clinical assessment | ROSZDRAVNADZOR Designated clinic |
| 8 | Secondary evaluation and supplementation request | ROSZDRAVNADZOR |
| 9 | Supplementary information submission | Manufacturer |
| 10 | Evaluation of supplementary information and decision of issuing registration certificate | ROSZDRAVNADZOR |
| 11 | Issue registration certificate | ROSZDRAVNADZOR |
Required document
- - Business license of manufacturer
- - ISO 13485 certificate
- - Techical document(TCF)
- - Manual
- - Clinical test report or relevant article
- - Risk Assessment data
- - Picture of product and sample
※ Above list is for necessary document for submission and depending on request from ROSZDRAVNADZOR extra document is required.
Point of contact
| Name | Position | Task | Tel | |
|---|---|---|---|---|
| Park Jinjae | Manager | KC, CB, CCC, CE etc Global Certificate | +82-2-2164-1479 | jjpark@ktr.or.kr |
