Armenia Medical Device Registration: Clinical Trials under EAEU Decision 29

1. Key takeaways

Clinical and clinical laboratory trials, called studies, of medical devices in the Eurasian Economic Union are governed uniformly by Council Decision No. 29 of 2016-02-12, whose technical documentation requirements are set out in Annex 3 of that decision for general devices and Annex 5 for in vitro diagnostic devices. The conclusion of GRZAN: clinical trials are not an optional bonus but a component of the chain of safety and effectiveness evidence within the registration dossier; the trial protocol must be finalized before the registration dossier is submitted, because the trial period is not counted within the official clock of Decision No. 46.

2. Legal basis

3. Expert insights

Insight 1: the Armenian authorities expressly list Decision No. 29 as an applicable legal act. In the Legislation section of the medical device regulatory portal of the Ministry of Health of Armenia, Decision No. 29 of the Council of the Eurasian Economic Commission of February 12, 2016, on the Rules for Conducting Clinical and Clinical Laboratory Trials, Studies, of Medical Devices, is listed among the legal acts applicable in the field of medical device circulation. GRZAN points out that this is an express adoption of the Union clinical trial rules by the Armenian competent authority; when Armenia acts as the reference state, clinical trials are organized directly under Decision No. 29 without any additional national overlay.

Insight 2: the technical documentation is a common input for clinical trials and production inspections. Article 35 of Decision No. 106 requires that, when applying for a periodic planned production inspection, the manufacturer submit the technical documentation of the medical device conforming to the requirements of Annex 3 of Decision No. 29, or, for in vitro diagnostic devices, the technical documentation conforming to Annex 5, submitted in electronic form in Russian and in a searchable format. GRZAN points out that the same technical documentation is used both for the registration assessment and for production inspections, so the two versions must be fully identical; a version discrepancy is the compliance gap most likely to be detected.

Insight 3: the trial period is not counted within the official clock. Under Article 14 of Decision No. 46 and the official Armenian explanation, the periods required to conduct technical tests, biological tests and clinical trials are not counted within the registration time limit. GRZAN points out that this dictates the scheduling logic: clinical trials should be completed before submission, otherwise the total project duration cannot be controlled; if supplementary trials become necessary during the assessment, the response to them should be managed as a separate, high-priority process so that the clock stoppage stays measurable.

Insight 4: the trials must be conducted by accredited institutions. The Union rules require the relevant trials and studies to be conducted by institutions holding the appropriate qualifications; after the amendments by Decisions No. 25 and No. 26 of 2022, the personnel qualification requirements for technical testing and biological evaluation laboratories were adjusted to require at least 2 years of professional work experience. GRZAN points out that when selecting a trial institution, its accreditation scope must be verified as covering the product category, and copies of the accreditation certificates should be retained (a practical estimate: the specific method of verifying the accreditation scope follows what the competent authority of the reference state publishes).

Insight 5: evidence can take the form of a first-party demonstration. Article 2 of the amended Decision No. 46 defines first-party evidence as the evidentiary materials, meaning documents, of the manufacturer of the medical device, including records of in-house trials and studies conducted by testing laboratories or centers accredited within the national accreditation systems of the member states, the results of clinical use of the medical device, and other materials. GRZAN points out that this provides a direct channel for using existing clinical use data, but the laboratory issuing the records must hold accreditation under the national accreditation system of a member state; private internal test reports without such accreditation will not qualify.

4. Practical recommendations

1. Build the technical documentation once and use it twice: prepare it under Annex 3 of Decision No. 29, or Annex 5 for IVDs, and use it for both the registration assessment and production inspections, with version control linking every release to both procedures.
2. Front-load the trials: complete the clinical trial and finalize the report before submitting the registration dossier, so that the clock stoppage under Article 14 is never triggered.
3. Verify institutional qualifications twice over: check both the accreditation scope of the trial institution and the qualifications of its professionals, including the 2-year experience requirement, and retain copies of the accreditation certificates.
4. Make good use of first-party evidence: organize existing clinical use results and trial records issued by accredited laboratories into the evidence chain, reducing the need for duplicate trials.
5. Respect the Russian searchable format: submit the technical documentation in electronic form in Russian and in a searchable format as required by Article 35, avoiding purely scanned files that reviewers cannot search.

5. Verification checklist

1. □ It has been confirmed that clinical trials are governed by Decision No. 29 and that the technical documentation is prepared under Annex 3, or Annex 5 for IVDs.
2. □ It has been confirmed that the technical documentation is identical in the registration assessment and in production inspections.
3. □ The accreditation scope of the trial institution has been verified as covering the product category.
4. □ The professional qualifications of the trial institution have been verified against the 2-year experience requirement.
5. □ It has been confirmed that the clinical trial is completed before submission of the dossier, or a separate supplementary process is in place.
6. □ First-party evidence materials, meaning clinical use results and records of accredited laboratories, have been organized.
7. □ It has been confirmed that the technical documentation is submitted in electronic, searchable form in Russian.

Regulatory information verified as of October 30, 2026.

GRZAN service note. GRZAN supports manufacturers in planning clinical and clinical laboratory trials for Eurasian Economic Union registration, including trial institution accreditation checks, evidence chain design, technical documentation alignment and Russian-language submission preparation. Regulatory monitoring is updated continuously and confirmed against the official sources cited above. For inquiries, contact info@grzanglobal.com.