Fillers and synovial fluid substitutes to enter Armenia only with an import certificate
High-risk injectable products – fillers for intradermal injection and synovial fluid substitutes for intra-articular injection – will be imported into Armenia only with a Ministry of Health certificate.
The government expanded the list of Harmonized System (HS) codes under which medical devices must be certified before import on October 29. The decision takes effect on the 30th day after official publication.
What happened
Imports of medical devices into Armenia are governed by government decision No. 429-N of March 30, 2023. The importer files an electronic application through the Single Window system. An expert organisation carries out an examination, after which the Ministry of Health issues an import certificate. An annex to the decision lists the Eurasian Economic Union (EAEU) HS codes covered by this procedure.
According to the justification for the draft, the decision’s application revealed that some high-risk products were being imported under codes missing from the list, and so were not certified. These are synovial fluid substitutes for intra-articular injection and fillers for intradermal injection.
The draft was submitted by the Ministry of Health, with Minister of Health Anahit Avanesyan listed as presenter on the agenda. It was prepared by the ministry’s Department of Pharmaceutical Policy and Medical Technologies and by the Scientific Centre of Drug and Medical Technology Expertise named after Academician Emil Gabrielyan CJSC. The additions follow proposals from the State Revenue Committee and importers of medical devices.
Who benefits
- Patients and aesthetic medicine clients. Fillers and joint preparations are injected, so a substandard product is a direct health risk. Every batch will now be examined before import.
- Honest importers. They already go through examination, and now the same rules apply to competitors who brought in similar goods under unregulated codes.
- The state. Customs and the Ministry of Health gain control over a segment that previously bypassed certification.
Who bears the costs. Importers of fillers and intra-articular preparations who brought them in without a certificate will now have to go through examination and pay the state fee. Under decision No. 429-N, the examination takes up to 6 working days for registered products and up to 10 for unregistered ones. The justification states that the change will not affect state budget revenue or spending in 2026.
What it means
The aesthetic injectables market comes under control. HS code 3304 normally covers cosmetics. During consultations, the Ministry of Economy proposed different wording, but the Ministry of Health rejected it. It explained that injectable products imported under this code are not cosmetics but medical devices.
Botox is not affected. The State Revenue Committee noted that injectables based on botulinum toxin type A may also be imported under code 3002 49 000 9. The Ministry of Health did not accept the proposal: such preparations (Botox, Dysport, Xeomin and similar) are registered as medicines worldwide and in Armenia and are regulated separately.
Code 3004 is narrowed in scope. This code is normally used for medicines. The new entry covers only medicine-like devices, such as isotonic solutions containing sodium hyaluronate used as implants to replace synovial fluid.
What to do
- Importers of fillers and intra-articular preparations: check the codes you import under. If they are 3004, 3304 99 000 0 or 3824 99 640 0, you will need a Ministry of Health import certificate once the decision takes effect. Applications go through the Single Window.
- Allow for the deadlines: up to 6 working days for examining registered products and up to 10 for unregistered ones. Time spent correcting incomplete documents is not included.
- Aesthetic medicine clinics: ask suppliers for the import certificate, as batches without one should not be imported once the decision takes effect.
- Watch for publication: the new rules apply from the 30th day after official publication.
