| 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

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©Beawire – July 2016, last updates Oct 2018.