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.
Last updated on November 22nd, 2021.
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.
Other Central America and the Caribbean Countries: Belize, Costa Rica, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua
For detailed device-specific compliance information for each market, including Panama, to expedite the preparation of your medical device or IVD registration application.
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