REGULATORY AUTHORITY: Medical devices are regulated by the DGRS (Dirección General de Registros Sanitarios).
CLASSIFICATION SYSTEM: Devices are classified according to risk, following the EU model of Classes I, IIa, IIb, III, and IV.
TIMEFRAME: The licensing process takes approximately six months.
LICENSE VALIDITY: Licenses issued in Honduras expire after five years.
AUTHORIZED REPRESENTATIVE: An authorized representative is required.
ADDITIONAL INFORMATION: The licensing process is expedited for devices which have already been approved in Canada or Japan.