| Registration Process for Medical Devices
Main approval for medical devices (medical device licensing or state registration) – registration certificate of Ministry of Health (Roszdravnadzor), approval from Russian Government.
Changing of registration certificate – used when manufacturer wants to change information in registration certificate except of technical specification of product.
Duplicate receiving – when manufacturer has no hard copy of registration certificate.
| Certification Process for Medical Devices
- for active medical devices – CU TR 020\2011
- for active and non-active medical devices (if applicable) – DoC GOST R
| For Manufacturers
- Why sanctions don’t work? – Flowchat about medical devices registered in Russia during last years.
- Subsidery for Russian Manufacturers: Subsidery for Russian Manufacturers
- How Government controls medical device market? Find answer here.
| What could be interesting:
1 – All about Market Surveillance by link.
2 – Technical regulation 2018 (articles) – by link.
3 – Medical device regulation (Russia) – additional information about approval documents by link
©Beawire – July 2016, last updates Oct 2018.