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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Guatemala, free of charge, to expedite the preparation of your medical device or IVD registration application.
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.
Last updated on February 9 2015.
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