Guatemala
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
: 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.

Last updated on February 9 2015.



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