Panama
REGULATORY AUTHORITY: 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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