Medical Device Registration and Approval in Honduras
General country-specific regulatory information is provided on this page for medical device registration and approval in Honduras.
Last updated on November 22nd, 2021.
Medical Device Regulations and Classification in Honduras
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.
Other Central America and the Caribbean Countries: Belize, Costa Rica, Cuba, Dominican Republic, El Salvador, Guatemala, Nicaragua, Panama
For detailed device-specific compliance information for each market, including Honduras, to expedite the preparation of your medical device or IVD registration application.
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