MEDICAL DEVICE REGISTRATION AND APPROVAL IN Guatemala

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 update: August 2023

Medical Device Regulations and Classification in Guatemala

REGULATORY AUTHORITY: The Ministry of Public Health and Social Welfare (DRCPFA) 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, and III

TIMEFRAME: The approval process takes between two and four months.

LICENSE VALIDITY:  Licenses issued in Guatemala expire after five years.

AUTHORIZED REPRESENTATIVE:  The LH must be an individual or a legal entity that owns the health license. It can be the legal manufacturer or an entity designated by the manufacturer. AG can be the LH.

 

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