| Registration Process for Medical Devices

Medical device registration – market access certification (Registration services for medical devices)

Medical and healthcare products are under Government control – Roszdravnadzor (a department of Ministry of Health) controls circulation of medical devices on the territory of Russian Federation (see here about government control).

For CIS countries please see here.

| Custom Union Technical Regulation (CU TR) 

• CU TR – TR 009/2011 – beauty products
• CU TR – TR 020/2011 – EMC

| State Registration for Cosmetics

State registration for cosmetics is applicable as exclusions from TR 009/2011 – as a part of Government control.

| GOST R 

GOST R certification is still acting in Russian Federation for medical devices.

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©Beawire – July 2016, last updates Aug 2018.