Armenia State Duty Law and Medical Device Registration Fees

1. Key takeaways

The state duties (State Duty) related to medical device registration are set by each member state: Article 3 of Decision No. 46 requires member states to approve the fee amounts by 31 December 2016, and Article 15 provides that the costs are borne by the applicant under member state legislation. The GRZAN conclusion: the specific amounts on the Armenian side are determined under the Law of the Republic of Armenia on State Duty; any amount that cannot be verified against official texts must be listed as a practical estimate, and unverified figures must never be cited. Budgets should be calculated in three segments: reference-state fees, recognition-state coordination fees, and change or reissuance fees. Blending all fee types into a single lump-sum figure is the most common budgeting mistake observed in registration projects.

2. Legal basis

3. Expert insights

Insight 1: Article 3, item a is the legal source for fee setting and expressly requires grading by complexity and workload. The provision requires member states to approve, by 2016-12-31, the amounts of the duties (taxes) or other mandatory payments provided for in the Rules, taking into account the complexity of the procedures and the scope of work performed in the reference state and the recognizing state, covering: first, registration of medical devices; second, expert review of the safety, quality and effectiveness of medical devices; third, changes to the registration dossier of a medical device; fourth, reissuance of the registration certificate. GRZAN note: this shows that the fees are not a single rate but are tiered by procedure type, and that the reference state and the recognizing state each charge separately.

Insight 2: Article 3, item b requires member states to designate competent bodies and notify the Commission. The same provision requires member states to identify the bodies (organizations) responsible for registration, changes to the registration dossier and other related procedures under the Rules, and to notify the Eurasian Economic Commission accordingly. GRZAN note: on the Armenian side, the registration function rests with the Ministry of Health and the identification function with the Scientific Center of Drug and Medical Technology Expertise (SCDMTE), per Government Decision No. 1795-Ն of 2022-11-24.

Insight 3: Article 15 locks the cost burden onto the applicant. The provision states that the costs arising from registration and expert review procedures, coordination of expert opinions, changes to the registration dossier (including the notification procedure), reissuance of the registration certificate, or coordination of expert opinions on registered medical devices are borne by the applicant under member state legislation. GRZAN note: the statutory bearer of the costs is the applicant, meaning the manufacturer or its authorized representative; advance payment arrangements between the representative and the manufacturer are an internal allocation and do not change who is liable toward the competent authority.

Insight 4: The timing of payment affects the progress of the procedure. Under Article 14, item a of Decision No. 46, where the authorized body (expert organization) of the reference state requests a copy of the payment receipt for the coordination procedure in the recognizing state, the period from the dispatch of the request to the receipt of the response is not counted in the authority’s clock. GRZAN note: this means payment of the recognizing-state fee is a precondition for the procedure to advance; failure to pay in time directly stops the clock (practical estimate: the specific payment deadline is subject to the notice of the competent authority).

Insight 5: A three-segment budget composition (GRZAN method).

4. Practical recommendations

1. Never cite unverified amounts: every fee statement in external materials must be traceable to the current text of the Law on State Duty or a published tariff of the competent authority; where it cannot be verified, mark it as a practical estimate.
2. Estimate the three segments separately: list reference-state, recognizing-state and change or reissuance costs separately instead of estimating with a single figure.
3. Reserve a currency buffer: duties are payable in Armenian drams, so reserve a buffer for exchange-rate movement and bank charges in the budget (practical estimate).
4. Manage payment receipts in the workflow: the payment receipt is a required document for acceptance and for advancing the coordination procedure; archive it together with the application form.
5. Agree on advance payment in the authorization: in the power of attorney or service agreement, state who advances the duties, the settlement cycle and how receipts are handed over.

5. Verification checklist

1. □ The legal sources of the fees, Article 3, item a and Article 15 of Decision No. 46, have been confirmed.
2. □ The applicable rates have been checked against the current text of the Law of the Republic of Armenia on State Duty (unverifiable items marked as practical estimate).
3. □ The budget has been estimated separately for the reference state, recognizing states and changes or reissuance.
4. □ A buffer for exchange-rate movement and bank charges has been reserved.
5. □ A synchronized archiving process for payment receipts has been established.
6. □ The advance payment and settlement mechanism for duties has been agreed in the power of attorney or service agreement.
7. □ It has been confirmed that inspection and testing costs are governed by separate contracts and not mixed into the duty budget.

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, fee budgeting, authorized representative services and quality management system consulting. For tailored advice on license-holder, import and fee matters, contact info@grzanglobal.com.