Medical Devices

By Monique Ferrer, Alfaro, Ferrer & Ramírez (AFRA)

Up to this date is not required in Panama to obtain market authorization (sanitary registration) for medical devices to be imported and commercialized in Panamanian territory as long as commercialization is intended for the private sector (i.e. private clinics; private hospitals; stores; pharmacies).

Nonetheless, when the commercialization of medical devices is destined to Government Institutions such as public hospitals or clinics it is mandatory to obtain authorization from the Ministry of Health.

“Certificate of Technical Criteria” is the document issued by the Ministry of Health, which approves the evaluation of the requirements and allows medical devices to be sold to the Government. The Executive Decree No. 468 of November 7, 2007 establishes the process, issuance, renewal and suspension of Certificates of Technical Criteria. This certificate is granted for a period of five years, renewable.

Please note however, that the National Assembly is discussing a project of law for medical devices in general and related products, which establishes the need for sanitary registration for all medical devices to be sold to either government institutions, private institutions and/or general public.

This sanitary registration/certificate would be different from the Certificate of Technical Criteria currently granted for medical devices to be sold to the government.

The bill also states that a National Direction for Regulation of Medical Devices will be created to be in charge of handling applications for licenses of operation (also a new condition included in the bill for companies to be able to commercialize medical devices), sanitary registration of medical devices as well as their suspension, modification, renewal and cancellation.

The regulated products within this bill are medical devices, equipment, instruments, spare parts, accessories, consumables, furniture in health, prosthesis, materials and supplies (related to the medical-surgical, imaging and dentistry groups).

Although this Project of Law states the need for sanitary registration of the afore mentioned products, it does not include neither the requirements nor the process to be followed in order to obtain such registration since, once -and if- this Project of Law is approved, an Executive Decree will set forth the requirements and process for registration as well as the costs associated with the same.
The discussion of this bill started on August 20, 2016 and is still ongoing.