| 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

| 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