Medical Device Testing in Russia and the EAEU

Medical device testing is a mandatory and highly critical stage of state registration in the Russian Federation and the EAEU. Research results confirm the quality, safety, and effectiveness of a product and form the basis of the registration dossier for Roszdravnadzor (the "Federal Service for Surveillance in Healthcare").

BRACE Law Firm provides comprehensive services for organizing testing: from selecting accredited facilities to auditing protocols to ensure that Roszdravnadzor will accept them.

Types of Testing and Regulatory Framework

In 2025, national legislation and EAEU rules (depending on the chosen registration path) regulate the testing procedure. The primary goal is to confirm that the product complies with applicable standards and GOSTs.

Summary Table of Primary Types of Research

Import of Samples for Testing: A Vital Stage

Testing foreign medical devices requires their legal import into the territory of the Russian Federation. This procedure requires strict compliance with customs and regulatory law.

How the Import of Samples Occurs

1. Obtaining Roszdravnadzor Permission: We prepare the application and the document package to obtain official permission for the import of samples (pursuant to Order of the Ministry of Health of Russia No. 201n).
2. Logistics Support: We advise on the labeling and transportation of samples to an accredited laboratory.
3. Customs Clearance: We help ensure correct declaration of the goods as "for testing purposes," which eliminates problems during subsequent registration.

Risk: Importing samples without Roszdravnadzor permission or using samples not intended for testing may lead to the rejection of the registration dossier and administrative liability.

Specifics of Testing under EAEU Rules

If you plan to register under the unified rules of the Eurasian Economic Union, the scope and methodology of testing will be based on EEC Council Decision No. 28.

Key EAEU Differences:

• The manufacturer must conduct testing in laboratories included in the EAEU unified register.
• Strict requirements apply to the formation of the clinical evidence report.
• The results of testing may be recognized in other member states of the Union (Armenia, Belarus, Kazakhstan, and Kyrgyzstan).

Why Errors in Testing Are Costly

An incorrectly drafted Testing Program and Methodology (the "TPM") or selecting a laboratory with an insufficient scope of accreditation leads to:

• Inquiries from expert organizations;
• The need for repeated, expensive research;
• Liability for the circulation of substandard medical devices.

BRACE Algorithm for Supporting the Testing Process

1. Regulatory Audit: We analyze technical documentation and determine the minimum necessary but sufficient scope of testing.
2. TPM Development: We advise and support the preparation of the testing program and methodology, ensuring compliance with all Roszdravnadzor requirements.
3. Import of Samples: We obtain import permission and oversee delivery to the laboratory.
4. Process Management: We monitor testing timelines and the correctness of interim certificates.
5. Final Audit of Protocols: We verify the final protocols for compliance with GOSTs and EAEU/RF standards before submission within the dossier.

Order Support for Medical Device Testing

BRACE experts will help you navigate the testing stage without unnecessary costs or legal risks. We know what Roszdravnadzor experts focus on and prevent errors before they occur.

Contact us for a preliminary evaluation of your project and the development of a testing strategy.