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.
* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.
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