Medical Device Registration in

Armenia

Ministry of Health

Ministry of Health

Regulatory Authority

Scientific Center for Drug and Medical Technology Expertise after Academician Emil Gabrielyan at the Ministry of Health of the Republic of Armenia

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

 

Looking for Medical Device Registration? Setup a meeting!

13 + 7 =