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.