Federal Service for Surveillance in Healthcare (Rosdravnadzor or RZN).
Medical devices are classified according to the EU risk-based model into Classes 1, 2a, 2b and 3.
New Registration: 10-16 months (including time to respond to RZN’s feedback and have additional documents reviewed by RZN)
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.
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.
Licenses issued in Russia do not expire.
The license transfer is applicable in Russia and entails a change of the AR.
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.
Last update May 01 2023