Medical Device Registration in


Medical Device Registration in Albania

Ministry of Health

Ministry of Health (MOH) Secretaria de Salud

Regulatory Authority

Direccion General de Registros Sanitarios

Medical Device Regulation


Official Language



Classes I, IIa, IIb, III, and IV

Medical Device Registration in Honduras

  • Product registration in Honduras is currently undergoing various reforms aimed at simplifying procedures and facilitating trade.
  • Determine the device classification.
  • Appoint an Authorized Representative.
  • Prepare the Technical File. Submit it to ARSA.
  • Once approved, the medical device can now be marketed in Honduras.

Documents Required

  • Application Form
  • Product Description
  • Manufacturer & Authorized Representative Information
  • Packaging details
  • Label, IFUs and Package Inserts
  • Free Sales Certificate
  • Letter of Authorization
  • Payment receipts
  • Risk Classification Report

Applicable QMS

ISO 13485

Registration Timeline

6 months

Authorized Representative


License Validity

5 years

Want to know more about this registration process?