MEDICAL DEVICE REGISTRATION AND APPROVAL IN Panama

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 update: August 2023

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.

TIMEFRAME: The licensing process takes approximately five 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

Find regulatory information from 140+ countries here

Tell me more

JUST SAY WHEN!

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 country-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform. You can start your product registration right now!

Start my free trial
Stay-Compliant Arazy Group Youtube Videos