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.

 

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