Armenia has been a member of the Eurasian Union (EAEU) since 2015, along with Russia, Belarus, Kazakhstan, and Kyrgyzstan. As of January 1, 2022, medical device registration in Armenia is only possible via the EAEU system, which allows the marketing of Medical Devices in all member states. National authorisations issued before that date remain valid until their expiry, after which EAEU registration will be required.

Registration Procedure (EAEU System)

1. Choice of Reference State
   The applicant must select an EAEU Member State (Armenia, Belarus, Kazakhstan, Kyrgyzstan or Russia) as the reference state, which will handle the application and the initial assessment.
2. Involvement of other Member States
   The applicant must involve at least one other EAEU Member State in the second step of the registration procedure; the Member State involved will approve or reject the decision taken by the Reference State.
3. Registration
   Dossier The application and related documentation (registration dossier) must be submitted electronically via the EAEU platform, operated by the Eurasian Economic Commission (EEC).
4. Technical evaluation and testing
   The Reference State carries out the technical evaluation of the documentation and manages any tests to verify the safety and performance of the device.
5. Manufacturing site inspection
   Regarding complex, innovative devices and sterile Class IIa, IIb and III devices, inspection is mandatory and conducted by the reference state according to GMP standards.
6. EAEU Registration Certificate
   At the end of the procedure, if approved by the Reference State and all other EAEU Member States involved, an EAEU Registration Certificate is issued.
   This EAEU certificate for Medical Devices is valid in Armenia and in the other member countries of the Eurasian Economic Union that have actively participated in the procedure.
   To market the medical device in other EAEU countries not initially involved, a mutual recognition procedure must be initiated.

Applicant

Manufacturers not established in the EAEU must appoint an Authorised Representative (AEO) based in one of the member countries.

Registration times

• Approximately 12-24 months, depending on the risk class.
• Production site inspections can add up to 90 days to the process.

Certificate Validity

Unlimited validity, unless there are regulatory changes or significant changes to the device.
The certificate is valid in Armenia and in the other EAEU member states that participated in the registration process.

Documentation Language and Labelling

• Documentation: Russian; some administrative documents may also require Armenian.
• Labelling and IFU (Instructions for Use): Russian and Armenian.

Useful info

The Decree of the Government of the Republic of Armenia No. 429 of March 30, 2023, outlines the procedure for importing Medical Devices into the territory of Armenia and lists the documents required for the expertise conducted for this purpose. Although the registration process is driven by the EAEU, this decree highlights specific national import requirements.