Certification Introduction
Medical devices exported to Russia or placed on the Russian market must obtain official registration and certification issued by Roszdravnadzor (Federal Service for Surveillance in Healthcare of the Russian Federation). As a member state of the Eurasian Economic Union (EAEU), unified EAEU medical device registration is mutually recognized among all union members, so no repeated application is required. Certification implements classified management based on product risk levels, and different risk levels correspond to different compliance procedures.
Laws and Regulations
The core regulatory framework includes:
- Federal basic law: Health Law of the Russian Federation (Federal Law No. 323)
- Main rules for medical device registration: State Registration Rules for Medical Devices (Decree No. 1416 of the Government of the Russian Federation)
- Detailed procedure rules: Order No. 321 of the Ministry of Health of the Russian Federation
- Unified technical regulation of the Eurasian Economic Union (Decision No. 46 of the EAEU Council)
- Decree No. 1684, which enters into force in 2025, updates requirements for electronic registration and clinical evidence, and shortens the approval cycle. Roszdravnadzor is responsible for approval and market supervision.
Technical Requirements
- Classified by risk into three categories: Class I (low risk), Class IIa/IIb (medium risk), Class III (high risk), with different compliance intensity corresponding to different categories
- The quality management system must comply with the requirements of ISO 13485/GOST R ISO 13485 standards
- Product performance and safety must comply with GOST R Russian national standards, and IEC international standards are applied in corresponding fields (e.g., electrical medical devices must comply with IEC 60601)
- Products in direct contact with the human body must complete biocompatibility testing; electrical products must complete electrical safety and environmental reliability testing
- Medium and high-risk products must provide standardized clinical trial data, while low-risk products can apply simplified clinical requirements
- Product labels and instructions must be in Russian, and mark the registration number, warning information and other content required by compliance regulations
Certification Process
Non-Russian manufacturers must first entrust an authorized representative legally registered in Russia, prepare a full set of application materials according to the product risk level, including the Russian-language registration application form, technical documents, quality management system certificate, test reports, clinical data, etc.; submit the application to Roszdravnadzor, and the regulatory authority will conduct preliminary document review and technical evaluation in sequence. Medium and high-risk products need to supplement factory audit or sample testing; after passing the review, the medical device registration certificate will be issued, and the certificate must be regularly renewed as required to maintain validity.
WANVE, as a professional technical service organization, provides one-stop full compliance support for enterprise export.