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.


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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