Certification Introduction

Medical devices exported to Russia or placed on the Russian market must obtain official registration and certification issued by Roszdravnadzor (the Federal Service for Surveillance in Healthcare of the Russian Federation). As a member state of the Eurasian Economic Union (EAEU), Russia currently accepts both RZN registration and EAEU registration. According to the transitional provisions, the RZN registration channel will be closed and EAEU registration will become mandatory after December 31, 2027.

Laws and Regulations

The core regulatory framework includes: The Federal Law No.323 on Protection of Public Health of the Russian Federation The Decree No.1684 on State Registration Rules for Medical Devices of the Russian Federation The Order No.885n on Conformity Assessment Procedures for Medical Devices of the Ministry of Health of the Russian Federation, etc.

Technical Requirements

In RZN registration, medical devices are classified by risk level into Class I (low risk), Class IIa (low-medium risk), Class IIb (medium-high risk), and Class III (high risk). A complete set of technical documents meeting RZN format requirements must be prepared and submitted, covering product information, R&D and production information, risk management report, obtained test reports, product photos, etc. Product samples must be sent to an authorized laboratory in Russia for local testing, including technical testing, toxicological testing, clinical evaluation (or human trials), EMC testing, etc. The quality management system must comply with the requirements of ISO 13485/GOST R ISO 13485 standards. According to Decrees No.135 and No.136, sterilized Class IIa, Class IIb and Class III products are subject to factory audit. All submitted documents must be translated into Russian and notarized, and product labels and packaging must comply with RZN requirements for marking and safety information labeling.

Certification Process

Select a local authorized representative as the applicant;

Prepare a complete set of technical documents meeting regulatory requirements, and complete translation and notarization in Russian;

Submit a test application to a qualified local laboratory;

Carry out tests including technical testing, toxicological testing, clinical evaluation (or human trials), EMC testing, etc.;

Conduct factory audit for sterilized Class IIa, Class IIb and Class III medical devices;

After obtaining test reports and the factory audit report, submit electronic registration documents to RZN and pay the government fees;

RZN reviews the registration documents, and issues the registration certificate after the review is passed;

The certificate is valid for a long term, and manufacturers must continuously fulfill obligations such as post-market surveillance, adverse event reporting, and registration document updating.

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