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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 .
Last updated on November 22nd, 2021.
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.
Other Central America and the Caribbean Countries: Belize, Costa Rica, Cuba, Dominican Republic, El Salvador, Honduras, Nicaragua, Panama
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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