Medical Device Registration in
Armenia
Ministry of Health
Regulatory Authority
Member of Eurasian Economic Union (EAEU)
Medical Device Regulation
Decree No. 46 – On the rules of registration and examination of safety, quality and efficiency of medical devices, Feb. 12, 2016
Decree No. 162 – On adopting the rules for state registration, re-registration, an extension of the term of the certificate of the medicinal product in the Republic of Armenia
Official Language
Armenian and Russian
Classification
Class I, IIa, IIb and III
Registration Process
- Determine the device classification
- Appoint an Authorized Representative
- Prepare the Registration Dossier and submit it to the competent authority
- Once approved, the medical device can be marketed in Armenia.
Documents Required
- Application Form
- Registration Dossier/Technical Documentation
- Clinical Studies Report – Testing Protocols, Clinical evidence
- User Manuals, IFUs, Labels
- Power of Attorney
- Other regulatory approval certificates
- Product Description
- Marketing History
- QMS
- Risk Management Plan
Post-market Requirements
- Serious threat to health – 2 calendar days
- Death or unexpected serious deterioration – 10 calendar days
- Other – 30 calendar days
Applicable QMS
ISO 13485
Registration Timeline
10 – 12 months
Authorized Representative
Yes
License Validity
Does not expire
Special Notes
All documents must be translated into Russian