EAEU Authorized Representative Liability under Decision No. 43: Armenia Implications

1. Key takeaways

Eurasian Economic Commission Council Decision No. 43 of 2026-04-27 (published 2026-05-19, effective 2026-06-18) elevates the authorized representative from a supporting interface party to a procedural entity standing on equal footing with the manufacturer. The GRZAN conclusion: this change cuts both ways for foreign manufacturers. On one hand, a local authorized representative can now deal with inspection bodies directly and sign inspection contracts, which speeds up communication and reduces cost. On the other hand, the representative now shares liability with the manufacturer at the inspection stage, so selection criteria and power-of-attorney wording must be upgraded at the same time. Manufacturers that keep legacy authorizations risk a document that no longer matches the legal role their representative actually performs.

2. Legal basis

3. Expert insights

Insight 1: The core of the change is the right to participate, not a mere agency right. The amendment stipulates that all inspection procedures must involve the manufacturer of the medical device and its duly authorized representative, and grants the representative three specific powers: first, to submit applications for periodic and unscheduled inspections; second, to coordinate with accredited inspection bodies, including communication and feedback on corrective actions; third, to sign inspection implementation contracts and related compliance documents. GRZAN note: this differs fundamentally from the traditional agency role of forwarding documents on behalf of the manufacturer — agency expresses the will of the manufacturer, whereas participation means acting in the representative’s own name within the procedure.

Insight 2: The liability structure shifts from sole to joint. Before the amendment, the manufacturer was the sole responsible entity for inspections, contracting and other core steps, and the authorized representative performed only a supporting interface function. After the amendment, the representative can jointly lead the process with the manufacturer, and when problems arise both parties bear liability together. GRZAN note: this means a failure of the authorized representative, such as missing the deadline for a periodic inspection application or failing to relay corrective action requirements, converts directly into compliance risk for the manufacturer, and vice versa.

Insight 3: Time limit rules are now quantified in parallel. The amendment provides that the duration of both periodic and unscheduled inspections must not exceed 90 working days, and that a periodic inspection application must be submitted at least 90 working days before the expiry of the previous inspection report. GRZAN note: Decision No. 106 already provided that the overall period for organizing and conducting a manufacturing inspection must not exceed 90 working days counted from the decision to start the inspection; the 2026 amendment extends the cap to periodic and unscheduled inspections and introduces, for the first time, a hard lead time for applications. The 90-working-day figure becomes a dual-purpose scheduling parameter.

Insight 4: Sharing sterilization facility results reduces outsourced sterilization costs. Under the amendment, where several manufacturers use the same sterilization facility, the previous practice of separately inspecting the production conditions of that facility for each client is no longer necessary — the assessment results on the facility’s production conditions obtained during an inspection of one manufacturer can be recognized and used for the others. The precondition is that the manufacturer holds a valid manufacturing inspection report that records the information on that sterilization facility. GRZAN note: when coordinating corrective actions, the authorized representative should make sure the inspection report fully documents the sterilization facility so the sharing mechanism can be invoked later.

Insight 5: A supporting methodological document was issued in parallel. The Executive Committee Recommendation No. 6 of 2026-04-07 issued methodological recommendations on inspections of medical device manufacturing. GRZAN note: recommendation-type documents create no obligations, but inspection bodies will reference them in practice; the authorized representative should include them in the input list for inspection preparation.

4. Practical recommendations

1. Rewrite the power of attorney now: add the three express authorizations to submit periodic and unscheduled inspection applications, to coordinate with accredited inspection bodies and relay corrective actions, and to sign inspection implementation contracts and compliance documents.
2. Add joint liability clauses: in the power of attorney and the service agreement, define the division of responsibilities at the inspection stage, the deadlines for information notification and the consequences of breach.
3. Upgrade selection criteria: include the capacity to handle inspection coordination and signing duties in the evaluation of authorized representative candidates, and verify staffing and language capability.
4. Run a 90-working-day countdown: work back from the 3-year validity of the inspection report and file the periodic inspection application at least 90 working days before expiry.
5. Document sterilization information: manufacturers using outsourced sterilization must ensure the inspection report fully records the sterilization facility information to preserve the evidence for the sharing mechanism.

5. Verification checklist

1. □ The publication date of Decision No. 43 of 2026 (2026-05-19) and its effective date (2026-06-18) have been confirmed.
2. □ The power of attorney includes the three authorizations for inspection applications, coordination and contract signing.
3. □ The power of attorney and service agreement include joint liability and information notification deadline clauses.
4. □ The authorized representative selection evaluation has been completed under the new criteria.
5. □ A ledger tracking the 3-year validity of inspection reports and the 90-working-day application lead time has been established.
6. □ It has been confirmed that outsourced sterilization facility information is recorded in the inspection report.
7. □ Executive Committee Recommendation No. 6 of 2026 has been added to the input list for inspection preparation.

Regulatory information verified as of October 30, 2026.

This guide was prepared and translated by GRZAN. GRZAN supports medical device manufacturers across the Eurasian Economic Union with registration, authorized representative services, inspection coordination and quality management system consulting. For tailored advice on Armenia license-holder, import and fee matters, contact info@grzanglobal.com.