REGULATORY AUTHORITY: 

Federal Service for Surveillance in Healthcare (Rosdravnadzor or RZN).

CLASSIFICATION SYSTEM:

Medical devices are classified according to the EU risk-based model into Classes 1, 2a, 2b and 3.

TIMEFRAME: 

New Registration: 10-16 months (including time to respond to RZN’s feedback and have additional documents reviewed by RZN)

SPECIAL REQUIREMENTS:

On-Site Audit: The decree No.135 that came into force in September 2022 introduced the Requirement on QMS Inspections for National Registration Procedure for product registration and amendment procedures for IIa sterile, IIb and III class medical devices. However, there is a transition period from January 2023 to December 2023 where QMS inspection is not mandatory and can be completed voluntarily.

Local Tests/Permit:

In-country local testing is required for all types of devices which include biocompatibility, toxicology, EMC testing, and measuring instrument/equipment.

Clinical Evaluation or Studies: A local clinical trial is required as part of the medical device registration requirements. The clinical trial for Class 2a, 2b, and 3 medical devices can only be conducted upon receiving the confirmation from the technical experts in Stage I which then become the pre-requirement to re-open the registration stage (Stage II). While for Class 1 and IVD medical devices, the clinical trial must be conducted before the submission to the RZN.

LOCAL FEES (New Application):

New registration (Class 1): USD 750

New registration (Class 2a): USD 1020

New registration (Class 2b): USD 1310

New registration (Class 3): USD 1730

LOCAL FEES (Manufacturer): 

No manufacturer registration fee is required.

LICENSE VALIDITY:

Licenses issued in Russia do not expire.

LICENSE TRANSFER: 

The license transfer is applicable in Russia and entails a change of the AR.

AUTHORIZED REPRESENTATIVE: 

The foreign manufacturer should appoint an organization or an individual entrepreneur who resides in Russia to become their authorized representative by issuing a power of attorney.

Other Central & East Asia Countries: Afghanistan, India, Japan, Kazakhstan, Kyrgyzstan, Nepal, Russia, South Korea, Sri Lanka, Taiwan, Tajikistan, Uzbekistan

Last update May 01 2023