Medical Device Registration and Approval in Guatemala

General country-specific regulatory information is provided on this page for medical device registration and approval in Guatemala .

We review our Regulatory Information frequently; please check back often for updates

Medical Device Regulations and Classification in Guatemala

REGULATORY AUTHORITY: The Ministry of Public Health and Social Welfare oversees regulation of medical and in-vitro diagnostic devices in Guatemala.

CLASSIFICATION SYSTEM: Guatemala follows the EU model of risk-based classification into Classes I, IIa, IIb, III and IV.

TIMEFRAME: The approval process takes between two and four months.

LICENSE VALIDITY:  Licenses issued in Guatemala expire after five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

 

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For detailed device-specific compliance information for each market, including Guatemala , to expedite the preparation of your medical device or IVD registration application.

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Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?

And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.

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