Armenia Medical Device Registration Exemptions 2026: Special Channels and Testing Waivers

1. Key takeaways

The EAEU medical device registration rules do not apply to two categories of devices by design: devices needed in a state of emergency, and devices used to diagnose emerging, naturally endemic or especially dangerous infectious diseases — both categories are governed by the legislation of the member states. In addition, there is a list of products exempt from technical testing (control materials, calibrators, cleaning solutions and culture media). The GRZAN judgment: exemption from registration in Armenian projects is a narrow lane and should not be used to design the main pathway; the genuinely routine burden-reduction openings are the exemption from technical testing and the import-document reduction for Class 1 devices. Companies that build their market-entry plan around an emergency or epidemic exemption will find that the exemption depends on an authority determination they cannot obtain commercially.

2. Legal basis

3. Expert insights

Insight 1: the exclusion in Article 1 of Decision No. 46 is a single, narrowly framed registration-free channel. The second paragraph of Article 1 of the rules as replaced provides that the rules do not apply to medical devices needed in emergency situations or to devices used for the diagnosis of emerging, naturally endemic or especially dangerous infectious diseases, whose circulation is regulated by the legislation of the member states. GRZAN notes three points: first, the trigger is an emergency situation or diagnosis of the specified infectious diseases, which is a public-health emergency attribute; second, what is excluded is not the registration obligation itself but the application of the Union registration rules, which are replaced by national procedures of the member state; third, a company cannot self-declare that it qualifies — the applicability must be established by the competent authority.

Insight 2: the list of products exempt from technical testing was expanded in 2022. After Council Decision No. 25 of 2022-03-17 amended Decision No. 28, the list of products not subject to technical testing was supplemented with control materials, calibrators, cleaning solutions and culture media, on the grounds that technical testing does not apply to such products. GRZAN notes that this is a substantive burden reduction for IVD companies: control materials and calibrators were previously often required to undergo technical testing, and they can now be removed from that stage of the documentation plan altogether.

Insight 3: the 2022 amendment also lowered the qualification threshold for laboratory personnel. The same amendment package reduced the mandatory work experience of testing laboratory specialists from 3 years to 2 years and standardized the forms of records for technical testing and for biological evaluation testing. GRZAN notes: this change widens the pool of eligible laboratories, and the compliance criteria companies use when selecting a testing site must be updated accordingly, otherwise valid laboratories are rejected on outdated standards.

Insight 4: biological evaluation results can be extended across a group of products. After Council Decision No. 26 of 2022-03-17 amended Decision No. 38, it became explicit that the study results for standard samples may be extended to a group of similar medical devices. GRZAN notes: for product lines with many models, such as dressings, catheters and infusion sets, this rule can significantly reduce testing cost and duration, but a group justification must be completed first (the same legal manufacturer, the same technical documentation, the same constituent materials, and the same scope and conditions of use).

4. Practical recommendations

1. Do not build the main pathway on the emergency lane: the exclusion for emergency and infectious-disease-diagnosis devices requires an authority determination, and commercial projects should not be planned on that basis.
2. Make the testing-exemption judgment first for IVD products: before control materials, calibrators, cleaning solutions and culture media enter a testing plan, record a written judgment on whether they fall within the exempt list.
3. Use the group-extension rule fully: for product lines with many models, organize a representative sample plus a group justification first, and write the extension mechanism of Decision No. 38 into the testing plan.
4. Update laboratory qualification standards: enter the requirement of 2 years of professional work experience into the supplier qualification checklist.
5. Claim the Class 1 import-document reduction: Class 1 non-sterile, non-IVD products may substitute batch quality certificates for the declaration of conformity under Annex 1, point 10.1, of Decision No. 429-Ն.

5. Verification checklist

1. □ It has been confirmed that the product does not fall within the exclusion of Article 1 of Decision No. 46, or an authority determination has been obtained.
2. □ Each IVD product has been judged item by item against the exempt list (control materials / calibrators / cleaning solutions / culture media).
3. □ The representative-sample justification for group extension of biological evaluation results has been completed and written into the testing plan.
4. □ The qualification standards for testing laboratories have been updated (2 years of professional experience required).
5. □ Whether the Class 1 product qualifies for the import-document reduction under point 10.1 has been confirmed.
6. □ The amendment content of Decisions No. 25 and No. 26 of 2022 has been merged into internal work standards.
7. □ Communication records with the competent authority on the applicability of the exclusion have been established.

Regulatory information verified as of October 30, 2026.

GRZAN services. GRZAN International assesses testing exemptions, group-extension strategies and import-document reductions for EAEU and Armenian projects. For inquiries, contact info@grzanglobal.com.