REGULATORY AUTHORITY:
Medical devices and IVDs are regulated by ARSA – Agencia de Regulación Sanitaria (Honduras), the national authority responsible for registration, control, and post-market surveillance.
CLASSIFICATION SYSTEM:
- Medical devices: Class I, Class IIa, Class IIb, and Class III
- IVDs: Class I, Class IIa, Class IIb, and Class III
TIMEFRAME:
- Medical devices & IVDs:
–Online submissions: ~10 working days
–Manual submissions: ~10–90 working days
LICENSE VALIDITY:
Licenses (Registro Sanitario) issued in Honduras are valid for 5 years for all classes of medical devices and IVDs.
Renewal must be submitted up to 5 months before expiry; late renewal is possible up to 6 months after expiration with penalty.
LOCAL FEES (New Application):
- Medical devices & IVDs:
Fees vary significantly depending on:
-Risk class
-Submission route (online vs. manual)
-Chosen resolution time
Typical ranges (indicative):
Risk Classification: ~USD 20–145
Product Registration: ~USD 110–580
(Exact amounts published by ARSA and subject to periodic updates.)
LICENSE TRANSFER:
License transfer is permitted and treated as a license amendment requiring approval.
AUTHORIZED REPRESENTATIVE:
A Local Authorized Representative (LAR) is mandatory.
The Registration Certificate Holder must appoint a local legal entity, which may also act as the importer and is responsible for regulatory compliance and post-market activities.
ADDITIONAL INFORMATION:
- Product registration (Registro Sanitario) is mandatory unless the device qualifies for an Exemption Report (Informe de Exoneración de Registro Sanitario).
- No reliance or expedited pathway exists for prior approvals from Canada, Japan, EU, or other reference markets.
- Local testing, local clinical studies, and foreign manufacturing site inspections are not required.
- A mandatory Technovigilance Regulation (Agreement 0185-ARSA-2025) is in force, imposing strict adverse event reporting and Field Safety Corrective Action (FSCA) obligations.
Other Central America and the Caribbean Countries: Belize, Costa Rica, Cuba, Dominican Republic, El Salvador, Guatemala, Nicaragua, Panama
