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