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
Medical Device Registration in Armenia
- 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