HOnduras
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

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.

Last updated on January 29 2015.



Interested in obtaining fast market approval for your medical device or IVD in Honduras? REQUEST A FREE QUOTE>

For more information on registration in Honduras, check out the following articles on our blog:
Country at a Glance: Honduras
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