Certification Introduction

The Eurasian Economic Union (EAEU, comprising Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan) implements mandatory unified market access registration and certification for medical devices, which is a statutory market access requirement. This system will replace the original decentralized registration systems of individual member states by 2028, realizing "one registration, valid for multiple member states".

Laws and Regulations

Core regulations include: Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) in the EAEU, Rules for Registration and Inspection of Safety, Quality and Efficacy of Medical Devices in the EAEU (approved by Commission Resolution No. 46), Rules for Clinical and Clinical Laboratory Testing (Research) of Medical Devices in the EAEU, etc. The above rules unify the general requirements and procedures for medical device registration and conformity assessment across the Union, ensuring that member states conduct review and supervision under a unified framework.

Technical Requirements

Medical devices are classified into Class I (low risk), Class IIa (low-to-medium risk), Class IIb (medium-to-high risk), and Class III (high risk) according to risk level A complete set of technical documents conforming to EAEU format requirements must be prepared and submitted, covering product information, R&D and production information, risk management report, obtained test reports, product photos, etc. Products must be sampled and sent to the reference country for local testing, including technical testing, toxicological testing, clinical evaluation (or human trials), EMC testing, etc. Products must comply with EAEU quality system management requirements and provide an ISO 13485 quality management system certificate; sterilized products and medium-to-high risk products are subject to official on-site audits. All submitted documents must be translated into Russian and notarized, and product labels and packaging must comply with the Union's marking and safety information labeling requirements.

Certification Process

Select a local authorized representative as the applicant, and determine the reference country and recognized member states in the EAEU information system;

Prepare a full set of technical documents meeting regulatory requirements and complete translation and notarization into 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.;

After obtaining the test reports, submit electronic registration documents to the reference country;

The reference country authority uploads the documents to the EAEU information system and conducts review;

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

The reference country issues the review conclusion and uploads it to the EAEU information system;

Recognized member states endorse the review conclusion of the reference country; after all recognized member states complete endorsement, registration is successfully approved and a registration certificate is issued; the certificate is permanently valid, and the manufacturer must continuously fulfill obligations such as post-market surveillance, adverse event reporting, and registration document update. WANVE provides one-stop full compliance support for enterprise export.