In order to guarantee safety and access to high quality medical devices in the public and private sectors, the Executive Decree No. 83 of April 26, 2019 was published in May 2, 2019 edition of the Official Gazette No. 28765-A. In this decree the Republic of Panama regulates Law 90 of December 26, 2017, in relation to medical devices and related products that exist and may exist in the national territory, in terms of import, manufacture, packaging, export, storage, marketing, re-export, distribution, among other activities.

Highlights of the regulation include the following provisions:

1. All medical devices and related products that are used in the national territory requires marketing authorization for their import, distribution and commercialization in the territory of the Republic of Panama, which will be valid for ten years.
2. In order to be acquired by any public institution, medical devices will require the issuance of a Technical Verification Certificate, which will be valid for five years. The main function of this document is to certify that the product complies with the technical specifications of the National Interinstitutional Technical Committee (CTNI).
3. Any public or private entity that is dedicated to manufacturing, packaging, import, export, distribution, marketing and / or storage of medical devices or related products in the national territory, must have an Operation License, which will be issued according to the type of establishment for a period of three years.
4. Free Sale Certificates will be issued for export purposes upon request of the manufacturers.

The executive decree regulates the requirements, procedures, rates and formalities required for the issuance, update, modification, cancellation, among others, of each of the documents described above by the National Directorate of Medical Devices and applies throughout the national territory, including fiscal or special customs territories, such as free zones, processing zones or their equivalent.
This Executive Decree No. 83 repeals the Ministry of Health´s Resolutions No. 598 of April 20, 2018, and No. 600 of April 23, 2018.

For more information, contact a member of our team.