Armenia Medical Device Regulation Update: EAEU Council Decision No. 144 (2021)

1. Key takeaways

Council Decision No. 144 of the Eurasian Economic Commission dated 2021-12-24 carried out a complete revision of the registration and examination rules approved by Council Decision No. 46 of 2016-02-12, entering into force 180 calendar days after official publication. The GRZAN conclusion: this revision was not a patch but a restructuring of the procedural framework — new procedures were added for the approval of expert opinions, the resolution of disagreements, changes under the notification procedure and the approval of expert opinions for registered devices, and the scope of application now expressly excludes devices needed in emergency situations and devices for diagnosing specific infectious diseases.

2. Legal basis

3. Expert insights

Insight 1: The procedural list of the revised rules is longer than the original. Article 1 of the revised rules provides that the procedures established by the rules include: ① registration of medical devices and examination of their safety, quality and effectiveness; ② approval of expert opinions; ③ resolution of disagreements in the approval of expert opinions; ④ changes to the registration file (including processing by notification); ⑤ reissuance of registration certificates; ⑥ approval of expert opinions for registered medical devices; ⑦ suspension and/or cancellation (invalidation) of registration certificates. GRZAN note: compared with the original, items ②③④⑥ are substantive procedural additions, showing that the Union has brought the full post-certification maintenance process into the rules.

Insight 2: The exclusion clause of the scope of application is written in explicitly. Article 1 of the revised rules also provides that the rules do not apply to devices needed in emergency situations or to devices used to diagnose emerging, naturally focal or especially dangerous infectious diseases; the circulation of such devices is governed by member state legislation. GRZAN note: this clause returns emergency devices to national law, and Armenian companies should switch to national procedures for such projects.

Insight 3: The terminology system has been redefined. The revised Article 2 defines a set of key concepts, including: safety of a medical device (the absence of unacceptable risks related to harm to human life, health and the environment); validation / verification (confirmation through objective evidence that requirements for intended use / specified requirements are fulfilled); acknowledging state (a member state whose authorized body or expert organization conducts the procedure for coordinating expert opinions of the reference state); first-party evidence (the manufacturer’s evidentiary materials, including self-test records and clinical use results, with tests by laboratories accredited in a member state’s national accreditation system); unified register of medical devices registered in the Union (an electronic database of devices registered under the rules); applicant (the manufacturer or its authorized representative); and quality of a medical device (the degree to which the device’s characteristics and performance correspond to the use intended by the manufacturer). GRZAN note: the unified register is written into the definitions, meaning registration results enter a Union-level electronic database and can be publicly queried.

Insight 4: Together with the protocol of 2021-12-30, a dual track of new and legacy devices. Decision No. 144 addresses the modernization of the rules themselves; the protocol amending the Agreement, signed on 2021-12-30 after the same Council session, addresses the treatment of legacy devices — devices previously registered under national rules may circulate until the expiry of their registration documents, and change applications may be submitted until 2026-12-31; from 2022-01-01 new devices are registered only under Union rules. GRZAN note: the two instruments must be read together to understand the market access landscape after 2022.

Insight 5: The entry-into-force mechanism is special. Decision No. 144 provides that it enters into force 180 calendar days after official publication, the longest waiting period among the Union instruments covered by this topic. GRZAN note: when checking the applicability of provisions, use the actual entry-into-force date computed as publication date plus 180 calendar days; do not judge by the date of adoption (2021-12-24).

Insight 6: Amendments continue. Council sessions of the Eurasian Economic Commission (for example the session of 2023-07-08) adopted further amendments to the registration and examination rules, concerning when new types of medical devices must be included in the GMDN and the Union catalog, and adjustments to the registration document lists for devices with low potential use risk and for in vitro diagnostic devices. GRZAN note: the registration rules are in a state of continuous revision, and companies should review the current version quarterly (practical estimate: specific amendment numbers and entry-into-force dates should follow the official Union legal portal).

4. Practical recommendations

1. Rebuild internal processes on the revised structure: map the seven procedures one by one to internal SOPs, especially the two new procedures of changes by notification and approval of expert opinions for registered devices.
2. Route emergency devices to national procedures: devices needed in emergencies and diagnostic devices for specific infectious diseases follow member state legislation; do not apply Union rules to them.
3. Make use of the unified register: registration results enter the Union unified register, which can be used to verify your own and third parties’ registration status.
4. Read the protocol together with the decision: new devices follow Union rules from 2022-01-01, while legacy devices are managed by document validity and the change deadline of 2026-12-31.
5. Quarterly review: include the current version of the registration rules in quarterly regulatory monitoring, focusing on adjustments to the document lists for low-risk devices and IVDs.

5. Verification checklist

1. □ Confirmed the adoption date of Decision No. 144 (2021-12-24) and its entry into force 180 calendar days after publication.
2. □ Internal SOPs rebuilt around the seven procedures of the revised rules.
3. □ Identified the exclusion of emergency devices and switched them to national procedures.
4. □ Confirmed the existence of the unified register and used it to verify registration status.
5. □ Managed new devices (Union rules only from 2022-01-01) and legacy devices (validity expiry plus 2026-12-31 change deadline) separately.
6. □ Included the registration rules in the quarterly review list.
7. □ Confirmed the current status of subsequent amendments, including adjustments to low-risk and IVD document lists (practical estimate noted).

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.