Medical Device Registration in
Ministry of Health
Direccion General de Registros Sanitarios
Medical Device Regulation
Classes I, IIa, IIb, III, and IV
- 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.
- 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