General country-specific regulatory information is provided on this page for medical device registration and approval in Panama.
We review our Regulatory Information frequently; please check back often for updates
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.
Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?
And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.
