Certification Introduction
The Eurasian Economic Union (EAEU, covering Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan) implements mandatory unified market access registration and certification for medical devices, which is a statutory access requirement. This system replaces the original decentralized registration systems of member states and realizes "one registration, access to all five countries". All medical devices intended to be placed on the EAEU market must complete this compliance procedure before they can be launched on the market.
Laws and Regulations
Core regulations include: the Agreement on Common Principles and Rules for Circulation of Medical Products within the Territory of the Eurasian Economic Union dated December 23, 2014, and the Rules for Registration and Examination of Medical Devices for Quality, Efficacy and Safety approved by Decision No. 46 of the Eurasian Economic Union dated February 12, 2016. These rules unify the general requirements and procedures for medical device registration and conformity assessment across the Union. Member states implement requirements under the unified framework, and there are no independent requirements with essential conflicts. Specific implementation details can be queried and confirmed on the official regulatory website of EAEU.
Technical Requirements
- Medical devices are classified into Class I (low risk), Class IIa, Class IIb and Class III (high risk) according to risk level. The classification result determines the complexity of the compliance path.
- A complete set of technical documents conforming to EAEU format requirements must be prepared, including product information, risk management report, performance verification report, etc. Except for some low-risk products, a clinical evaluation report is required.
- Medium and high-risk products must comply with EAEU GMP requirements, which are equivalent to the requirements of ISO 13485 quality management system, and are subject to official audit.
- All submitted documents must be in Russian. Product labels and packaging must comply with the EAEU's requirements for marking and safety information labeling.
Certification Process
- Complete risk classification of medical devices in accordance with EAEU regulations
- Prepare a complete set of compliant technical documents and complete the corresponding clinical evaluation
- Conduct conformity assessment: Class I products can issue a self-declaration of conformity by the manufacturer; Class IIa, IIb and III products require technical document and quality management system audit completed by an EAEU accredited body
- Submit the registration application to the competent authority of the member state through a legally authorized representative located in an EAEU member state, cooperate with expert review and supplement materials as required
- After passing the review, the product will be entered into the unified EAEU registration system and the registration certificate will be obtained. The certificate is valid for a long term, and the manufacturer must continuously fulfill the obligations of post-market surveillance and adverse event reporting.
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