MEDICAL DEVICE REGISTRATION AND APPROVAL IN Honduras

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 update: December 2022

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.

 

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