Medical Device Registration in

Honduras

Ministry of Health

Ministry of Health (MOH) Secretaria de Salud

Regulatory Authority

Direccion General de Registros Sanitarios

Medical Device Regulation

N/A

Official Language

Spanish

Classification

Classes I, IIa, IIb, III, and IV

Registration Process

  • 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

Yes

License Validity

5 years

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