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Medical devices are regulated by the DGRS (Dirección General de Registros Sanitarios).
Devices are classified according to risk, following the EU model of Classes I, IIa, IIb, III, and IV.
The licensing process takes approximately six months.
Licenses issued in Honduras expire after five years.
An authorized representative is required.
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