: 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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