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.
Last updated on January 29 2015.
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For more information on registration in Honduras, check out the following articles on our blog: Country at a Glance: Honduras