Medical devices are regulated by Minsa or the Ministerio de Salud (Ministry of Health). CLASSIFICATION SYSTEM:
Devices are classified according to risk, following the EU model of Classes I, IIa, IIb, III, and IV. TIMEFRAME:
The licensing process takes approximately two months. LICENSE VALIDITY:
Licenses issued in Panama are valid for five years. AUTHORIZED REPRESENTATIVE:
An authorized representative is required. ADDITIONAL INFORMATION:
An additional technical file is required to register a product that is new to Panama.
Last updated on February 2 2015.
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