Armenia Medical Device QMS Rules 2026: Decision No. 43 and the Transition to 2027

1. Key takeaways

The two most important changes of this round both point to 2026–2027: first, Council Decision No. 43 of 2026-04-27 (published 2026-05-19, in force 2026-06-18) amended the quality management system requirements; second, Armenia extended its transition period to December 31, 2027. The GRZAN conclusion: the former raises the threshold for procedural participants (equal standing of the authorized representative plus hardened inspection deadlines), while the latter widens the time window for imports; the combined strategy is to use the transition period to buy time and use the new QMS rules to reduce long-term maintenance cost.

2. Legal basis

3. Expert insights

Insight 1: The four changes of Decision No. 43 are already in force at Union level. After amending Decision No. 106, the four substantive changes are: ① the authorized representative enjoys the same compliance participation rights as the manufacturer (submitting applications for scheduled and unscheduled inspections, coordinating remediation with the inspection body, signing inspection service agreements); ② the duration of both scheduled and unscheduled inspections must not exceed 90 working days; ③ an application for a scheduled inspection must be submitted at least 90 working days before the expiry of the previous inspection report; ④ inspection results for the same sterilization facility may be shared between different manufacturers (provided the manufacturer holds a valid inspection report stating the information on that sterilization facility). GRZAN note: of these four, item ① changes the responsibility structure, items ② and ③ change the scheduling logic, and item ④ changes the cost structure.

Insight 2: The transition period extension is anchored in Armenian national law. The official pages of the Ministry of Health of Armenia state that under the transition period established by the Law on Medical Care and Services for the Population, until December 31, 2027, unregistered medical devices may circulate in parallel with registered devices in Armenia; during the transition period, import regulation of medical devices continues under Government Decision No. 429-Ն of 2023-03-30. GRZAN note: this is a confirmation at the national law level, and planning for Armenia should follow the national law wording.

Insight 3: Protocol progress at the regional level needs continuous tracking. Belarus approved two draft protocols as a negotiation basis on 2025-12-17 by Presidential Order No. 441; the content includes updating the list of devices exempt from registration and extending the transition period to 2027-12-31. GRZAN note: the completion of domestic procedures for the two protocols in each member state should follow official publications, and companies should continuously track the approval progress (practical estimate: the approval and entry-into-force status of the protocols in each member state follows official publications).

Insight 4: The combined effect of the two changes, as tabulated by GRZAN.

Insight 5: Three hard points on the timeline. GRZAN note: between 2026 and 2027 companies must watch three dates at the same time — ① the entry into force of Decision No. 43 on 2026-06-18 (already in force; authorization letters must be rewritten); ② the deadline of 2026-12-31 for change applications for legacy devices registered under national rules; ③ the end of the Armenian transition period on 2027-12-31.

4. Practical recommendations

1. Rewrite the authorization letter now: the already effective Decision No. 43 requires the authorization letter to cover the three authorities of inspection applications, coordination and contract signing; complete the rewrite before the next inspection.
2. Rebuild the scheduling model: enter the combination of an inspection ceiling of 90 working days, an application lead time of 90 working days and a report validity of 3 years into the annual quality plan.
3. Use the sterilization sharing mechanism fully: manufacturers with outsourced sterilization should ensure the inspection report states the sterilization facility information and invoke the sharing mechanism to cut duplicate inspection cost.
4. Run transition and registration in parallel: use the transition period for imports while starting Union registration to avoid supply interruption after 2027-12-31.
5. File legacy change applications before 2026-12-31: holders of registration certificates issued under national rules should submit change applications ahead of that date.

5. Verification checklist

1. □ Confirmed the publication date of Decision No. 43 (2026-05-19) and its entry into force (2026-06-18).
2. □ Authorization letter rewritten (three authorities: inspection application, coordination, contract signing).
3. □ The 90 working day ceiling and the 90 working day lead time entered into the annual quality plan.
4. □ Confirmed that the outsourced sterilization facility information is stated in the inspection report.
5. □ Confirmed the Armenian transition period deadline of 2027-12-31.
6. □ Union registration started in parallel to avoid supply interruption after the transition period expires.
7. □ Confirmed whether change applications for legacy devices are submitted before 2026-12-31.

Regulatory information verified as of October 30, 2026.

About GRZAN: GRZAN supports medical device manufacturers entering Armenia and the Eurasian Economic Union with regulatory registration, quality management systems, post-market surveillance and import clearance compliance. For inquiries, contact info@grzanglobal.com.