Armenia Unregistered Medical Device Circulation 2026: Transition-Period Import Rules and Action Plan

1. Key takeaways

During the Armenian transition period, unregistered medical devices may circulate in parallel with registered medical devices, with a cut-off date of December 31, 2027; throughout the transition period, imports of medical devices remain governed by Government Decision No. 429-Ն of 2023-03-30. The GRZAN operational judgment: the transition period is an import window, not an inspection-free channel — when importing an unregistered device, four categories of documents must still be submitted (marketing evidence from the country of origin or an IMDRF member country, batch-by-batch quality certificates, instructions for use, and full-color images of the labeling), and the import (compliance) certificate is a single-use authorization valid for 1 year that expires once customs clearance is completed. Reading the transition period as permission to sell without documents is the most common source of compliance incidents in Armenian projects.

2. Legal basis

3. Expert insights

Insight 1: the legal effect of the transition period is parallel circulation, not exemption from the registration obligation. The official page of the Ministry of Health describes the transition period as follows: within the transition period established by law, until December 31, 2027, the Republic of Armenia permits the parallel circulation of unregistered and registered medical devices. GRZAN notes: the permission to circulate applies to the distribution stage and does not waive the registration requirement itself under Decision No. 46. Any product intended for long-term operation on the market still needs to complete Union registration before the window closes.

Insight 2: import management during the transition period continues to apply Decision No. 429-Ն. The Ministry of Health states explicitly that during the transition period, the regulation of medical device imports into the Republic of Armenia continues to be implemented under Government Decision No. 429-Ն of March 30, 2023. GRZAN notes that this sentence locks the transition period to the import certificate system: any device entering Armenia through import, whether registered or not, must go through the import (compliance) certificate procedure. There is no separate, lighter customs lane for unregistered devices.

Insight 3: the four document categories for unregistered devices are a hard threshold. To perform the expert assessment required for the import of an unregistered medical device, the following must be submitted: a) a document evidencing approval for use (state registration) in the country of origin or in a member country of the International Medical Device Regulators Forum (IMDRF), or a reasoned reference to such a document, including a declaration of conformity referencing the relevant register; b) a certificate of quality conformity for each batch of the imported medical device (such as a final inspection report, a batch release certificate, a batch release statement, a certificate of analysis or another equivalent document issued by the manufacturer or its authorized representative, stating the batch or lot number); c) instructions for use or a link to an electronic version; and d) clear full-color images or drawings of the labeling. GRZAN notes: IMDRF member countries include the European Union, the United States, Canada, Japan, Russia, China, South Korea, Singapore, the United Kingdom, Brazil and Australia, so a Chinese manufacturer can use an NMPA registration certificate as the item a evidence.

Insight 4: the 2024 amendment opened a burden-reduction lane for Class 1 products. Government Decision No. 1619-Ն of 2024-10-17 added point 10.1 to Annex 1 of Decision No. 429-Ն: when importing medical devices of Class 1 risk (excluding sterile devices and devices for in vitro diagnosis), a certificate of quality conformity for each batch, or another document evidencing the quality of that batch, may be submitted in place of a declaration of conformity. It also added point 10.2: when importing second-hand medical devices, the applicant must indicate in the commercial description of the product field of the single-window electronic system that the product is second-hand.

4. Practical recommendations

1. Treat the transition period as a time window, not an exemption: even when importing under the unregistered route, start Union registration in parallel to avoid supply interruption after 2027-12-31.
2. Prepare quality certificates batch by batch: Decision No. 429-Ն requires batch-level quality documents, so the batch release certificate must be made a mandatory shipping attachment in the order process.
3. Use the IMDRF channel: Chinese manufacturers should prioritize the combination of an NMPA registration certificate and a declaration of conformity referencing the register, as the item a evidence.
4. Claim the Class 1 reduction: qualifying Class 1 non-sterile, non-IVD products may substitute batch quality certificates for the declaration of conformity under point 10.1.
5. Plan around the single-use certificate: the import (compliance) certificate expires after customs clearance and cannot be reused across shipments, so it must be built into the logistics plan.

5. Verification checklist

1. □ It has been confirmed that the product will enter Armenia as an unregistered device under the transition-period import route, and the long-term compliance pathway has been assessed in writing.
2. □ The current consolidated version of Decision No. 429-Ն (including the 2023 and 2024 amendments) has been retrieved from arlis.am.
3. □ Marketing authorization evidence from the country of origin or an IMDRF member country has been prepared.
4. □ A process for obtaining batch quality conformity certificates before shipment has been established.
5. □ Instructions for use in Russian or Armenian, or a link to an electronic version, have been prepared.
6. □ Clear full-color images or drawings of the labeling have been prepared.
7. □ Whether the product qualifies for the Class 1 reduction under point 10.1 has been confirmed.
8. □ It has been confirmed that the import (compliance) certificate is single-use and expires after customs clearance, and this has been built into the logistics plan.

Regulatory information verified as of October 30, 2026.

GRZAN services. GRZAN International manages Armenian import (compliance) certificate applications, IMDRF evidence packages and parallel Union registration programs for manufacturers. For inquiries, contact info@grzanglobal.com.