Armenia Medical Device Registration Certificate: Suspension and Cancellation Rules

1. Key takeaways

The procedures for suspension and cancellation (invalidation) of registration certificates are written into the scope of Decision No. 46; in Armenia, both decisions may be adopted only by the Ministry of Health, and together with refusal of registration, reissuance of the certificate and amendments to the certificate they form part of the Ministry’s 6 statutory powers. The GRZAN conclusion: the direct market consequence of suspension or cancellation is that the product loses its legal right to circulate, and it also affects already issued import (compliance) certificates, because the import certificate relies heavily on the Armenian national registration status of the device.

2. Legal basis

3. Expert insights

Insight 1: The revised Article 1 lists suspension and cancellation among the procedures governed by the rules. The article provides that the procedures established by the rules include registration and examination, approval of expert opinions, resolution of disagreements, changes to the registration file (including the notification procedure), reissuance of registration certificates, approval of expert opinions for registered devices, and the suspension and/or cancellation (invalidation) of medical device registration certificates. GRZAN note: after the 2021 revision by Decision No. 144, the approval of expert opinions for registered medical devices is listed as an independent procedure, which means that even after certification a renewed approval of the expert opinion may be required — an additional maintenance obligation beyond suspension and cancellation.

Insight 2: The Armenian list of 6 powers. The official explanation of the Ministry of Health of Armenia states that the Ministry performs registration, refusal of registration, suspension of registration, cancellation of registration certificates, reissuance of registration certificates and amendments to registration certificates — 6 powers in total — based on expert opinions issued by the expert organization designated by a government decision. GRZAN note: all six powers are premised on the expert opinion, so the substantive battlefield against suspension or cancellation lies at the technical level of the SCDMTE, not at the administrative level.

Insight 3: Trigger situations are linked to surveillance results. Article 2 of Decision No. 174 lists the identification and prevention of the circulation of devices that do not meet the general safety and effectiveness requirements among the aims of surveillance; Article 3 provides that surveillance includes the collection, recording and analysis of adverse event (incident) information and the adoption of the relevant decisions. GRZAN note: the conclusions of post-market surveillance are an important input to suspension and cancellation, which is why the post-market system must be connected with the QMS.

Insight 4: Knock-on effect on import (compliance) certificates. Import of unregistered devices relies on proof of marketing in the country of origin or in an IMDRF member state; import of registered devices relies on a copy of the Armenian registration certificate. GRZAN note: once a registration certificate is cancelled, a registered device reverts to unregistered status and the import documentation requirements change accordingly; in addition, the refusal situation of an imported device lacking Armenian national registration under Article 47.2 applies again (except where the law provides otherwise; the provisions should be checked against the current text on arlis.am).

Insight 5: The three-stage response structure, as applied by GRZAN.

4. Practical recommendations

1. Prevent first: most triggers of suspension and cancellation come from post-market surveillance and manufacturing inspections; run both as routine compliance activities.
2. Technical rebuttal before administration: upon receiving an adverse signal, first submit technical rebuttal and remediation evidence to the SCDMTE, then handle the administrative procedure.
3. Assess the import impact in parallel: as soon as a suspension or cancellation occurs, immediately re-evaluate the import documentation requirements (whether the device has reverted to unregistered status).
4. New post-certificate maintenance duty: monitor the approval of expert opinions for registered devices introduced by the 2021 revision and reserve response resources.
5. Authorized representative readiness: under Decision No. 43 of 2026 the authorized representative may lead inspection coordination, and its responsiveness directly affects the outcome of the disposition.

5. Verification checklist

1. □ Confirmed that suspension and cancellation procedures are written into Article 1 of Decision No. 46.
2. □ Confirmed that the Ministry of Health of Armenia is the sole decision-making body and that the SCDMTE provides the expert opinion.
3. □ Confirmed the new procedure for the approval of expert opinions for registered devices introduced in the 2021 revision.
4. □ Established a linkage mechanism between post-market surveillance and the QMS.
5. □ Prepared standard templates for technical rebuttal and remediation evidence.
6. □ Assessed the knock-on effect of suspension and cancellation on import (compliance) certificate documentation.
7. □ Confirmed the authorized representative’s duties in inspection coordination and remediation (Decision No. 43 of 2026).

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.