Armenia Registration Certificate Holder Changes: Rename, Transfer and Representative Replacement

1. Key takeaways

Changes of the certificate holder after issuance fall into 3 categories handled separately: renaming (a change of the name of the same legal entity), transfer (the movement of the rights and obligations of the registration certificate to another entity), and replacement of the authorized representative (a change of the representative of the applicant). The GRZAN conclusion: under the Union rules all three fall into the change of registration dossier procedure (including the notification procedure newly added in the 2021 revision), but the evidence requirements differ — renaming relies on registration evidence, transfer on documents of succession to the rights and obligations, and replacement of the representative on the new power of attorney together with proof of termination of the old authorization. Planning the change type before gathering documents saves an entire review cycle.

2. Legal basis

3. Expert insights

Insight 1: The 2021 revision opened a notification procedure for changes. Article 1 of the revised Rules provides that the procedures established by the Rules include changes to the registration dossier (including by way of notification). GRZAN note: when planning a change, companies should first determine whether the change item falls into a category eligible for the notification procedure; using it avoids the full expert review process and is the key channel for reducing maintenance costs (practical estimate: the definitive list of items eligible for the notification procedure is subject to the annexes of the Rules and the approach of the competent authority).

Insight 2: Replacement of the authorized representative carries greater weight after 2026. Decision No. 43 of 2026 requires that all inspection procedures involve the manufacturer and its duly authorized representative, who is entitled to submit inspection applications, coordinate with inspection bodies and sign inspection contracts, and who shares liability with the manufacturer. GRZAN note: replacing the authorized representative is no longer a matter of changing a mailing address; it is a change of the responsible entity in inspection procedures, and the handover of ongoing inspection matters and the division of liability must be handled at the same time.

Insight 3: Changes for legacy devices face an independent deadline. Under the Protocol amending the Agreement signed on 2021-12-30, medical devices previously registered under national member state rules may circulate until the documents proving their registration expire; changes to the registration documents of such devices are permitted where the application is submitted before 2026-12-31. GRZAN note: companies holding registration certificates issued under national rules must submit any planned change application, including changes of the holder, before 2026-12-31; after that date the change channel closes.

Insight 4: Article 15 determines who bears the change costs. The provision states that the costs arising from procedures such as changes to the registration dossier (including the notification procedure) are borne by the applicant under member state legislation. GRZAN note: the statutory bearer of the change costs is the same as for the initial registration, and the change agreement between the entities should allocate these costs expressly.

Insight 5: An evidence comparison across the three change types (GRZAN working table).

4. Practical recommendations

1. Classify before launching: the first step of any change project is to determine whether it is a renaming, a transfer or a replacement of the authorized representative, then apply the corresponding evidence list.
2. Re-sign the power of attorney under the new rules: when replacing the authorized representative, re-sign the power of attorney per Decision No. 43 of 2026 and obtain proof of termination of the old authorization at the same time.
3. Beat the 2026-12-31 deadline for legacy changes: holders of certificates issued under national rules should submit change applications ahead of that date.
4. Update labels and instructions in sync: after renaming, update the manufacturer information on labels, instructions for use and packaging artwork in sync to avoid inconsistent market versions.
5. Write change costs into the agreement: in the change agreement, state who bears the costs of the change procedure and how settlement works.

5. Verification checklist

1. □ The change type (renaming, transfer or authorized representative replacement) has been determined and the corresponding evidence list applied.
2. □ It has been assessed whether the change qualifies for the notification procedure newly added in the 2021 revision.
3. □ When replacing the authorized representative, the power of attorney has been re-signed per Decision No. 43 of 2026 and proof of termination of the old authorization obtained.
4. □ For legacy devices registered under national rules, it has been confirmed that the change application is submitted before 2026-12-31.
5. □ After renaming, the labels, instructions for use and packaging artwork have been updated in sync.
6. □ The bearer of the change procedure costs has been specified in the change agreement.
7. □ The handover plan for manufacturing inspection reports and periodic inspection arrangements after a transfer has been confirmed.

Regulatory information verified as of October 30, 2026.

This guide was prepared and translated by GRZAN. GRZAN provides end-to-end regulatory services for medical device manufacturers entering Armenia and the Eurasian Economic Union, including registration, dossier changes, authorized representative services and lifecycle compliance management. For tailored advice on license-holder, import and fee matters, contact info@grzanglobal.com.