General country-specific regulatory information is provided on this page. Become a LICENSALE.COM
user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.
Medical devices are regulated by Minsa or the Ministerio de Salud (Ministry of Health).
Devices are classified according to risk, following the EU model of Classes I, IIa, IIb, III, and IV.
The licensing process takes approximately two months.
Licenses issued in Panama are valid for five years.
An authorized representative is required.
An additional technical file is required to register a product that is new to Panama.
Last updated on February 2 2015.
Interested in obtaining fast market approval for your medical device or IVD in Panama? REQUEST A FREE QUOTE>