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.
Other Central America and the Caribbean Countries: Belize, Costa Rica, Cuba, Dominican Republic, El Salvador, Honduras, Nicaragua, Panama
