Medical Device Registration and Approval in Panama

General country-specific regulatory information is provided on this page for medical device registration and approval in Panama. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Panama, to expedite the preparation of your medical device or IVD registration application.

 

Medical device regulations and classification in 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.

Other Central America and the Caribbean Countries:

Belize, Costa Rica, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua

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