During the transitional period established by the Law of the Republic of Armenia “On Medical Care and Services to the Population”, until 31 December 2027, the circulation of unregistered medical devices is also permitted in the territory of the Republic of Armenia alongside registered medical devices.
The Ministry of Health of the Republic of Armenia carries out the registration of medical devices, refusal of registration, suspension of registration, invalidation of registration certificates, issuance of duplicates of registration certificates, and amendments to registration certificates, based on the expert opinion of an expert organization designated by a Government decision.
The national procedure for the registration of medical devices is currently under development.
At present, the state registration of medical devices in the Republic of Armenia is carried out in accordance with the Rules for Registration of Medical Devices and Examination of Their Safety, Quality and Efficacy, approved by Decision No. 46 of the Council of the Eurasian Economic Commission dated 12 February 2016.
The applicant initiating the registration procedure is the manufacturer of the medical device or its authorized representative.
A medical device subject to registration must comply with the general requirements established by Decision No. 27 of the Council of the Eurasian Economic Commission dated 12 February 2016, “On Approval of the General Requirements for the Safety and Efficacy of Medical Devices and the Requirements for Their Labelling and Operational Documentation”.
Studies conducted for the purpose of demonstrating the safety, efficacy and quality of medical devices subject to registration must be conducted in accordance with the requirements of the relevant EAEU sector-specific decisions and guidelines.
The requirements for the state registration of medical devices, as well as the relations between the registering authority and the applicant, are established by the above-mentioned Rules.
Required Documents
- Application in the form established by Decision No. 46 of the Council of the EEC dated 12 February 2016.
- Document package in the form established by Decision No. 46 of the Council of the EEC dated 12 February 2016.
- Document confirming payment of the state duty.
Procedure and Timeframes
- Expert assessment in the reference Member State — up to 60 working days from the date of acceptance of the application.
- Coordination of the expert opinion by the recognition Member States — up to 30 working days.
- Adoption of the registration decision — within 10 working days after completion of the coordination process.
- Preparation and issuance of the registration certificate — up to 10 working days.
Important Notes on Timeframes
- The expert assessment period does not include the period required for the applicant to provide additional data and documents requested during the assessment.
- The periods required for conducting technical, biological and clinical trials, as well as for the assessment/audit of the quality management system, are not included in the registration timeframe and depend on the complexity of the medical device.
A step-by-step guide to the EAEU registration process is available at the following link.
https://portal.eaeunion.org/_layouts/15/cit.eec.impop/portal.landings/medicaldevices.aspx
The amount of state duties related to the registration of medical devices in the Republic of Armenia is established by the Law of the Republic of Armenia On “State Duty”.