New products related to the health emergency by COVID-19 are declared as Non-Available Vitals.

Since the issuance of Minute Num. 3 dated March 24, 2020, the Colombian Sanitary Authority, INVIMA, has declared certain products, subdivided in 16 categories, as NON-AVAILABLE VITALS, which as such, can be commercialized without a sanitary registration. These products, including, amongst others, those related to the protection of health personnel for the assistance of patients diagnosed with COVID-19 (glasses, gloves, medical gowns, etc.), medical devices for the treatment of respiratory diseases, as devices for oxygen therapies, breathing therapies, and nebulizers, mechanical ventilation for assisted breathing, cardio defibrillators, and devices for the constant monitoring of vital sins, etc. The complete list may be consulted in the following link :HTTPS://WWW.INVIMA.GOV.CO/SALA-ESPECIALIZADA-DE-DISPOSITIVOS-MEDICOS-Y-REACTIVOS-DE-DIAGNOSTICO-IN-VITRO

In this regard, by means of Minute Num. 4 dated April 17, 2020, the Specialized Board for Medical Devices and Diagnostic Chemical Reagents of the INVIMA, made some precisions, as follows:

1. It clarified that the elements for healthcare personnel protection such as protection glasses, ventilators, facemasks, facial protectors, biological gowns, are considered medical devices son long as the manufacturer specifically declares its use for healthcare professionals in hospital environments.
2. It added to the list provided in Minute Num. 3 dated March 24, 2020: in Category 10 (DIAGNOSTIC PORTABLE DEVICES): a) Stethoscopes, b) Computed Axial Tomography and in Category 14 (COLLECTION, STORAGE AND SAMPLE TRANSPORTATION DEVICES), fridges and refrigerators.
3. Finally, it made some precisions regarding some specific products which have been requested as Non-Available Vitals in the course of the emergency, namely:

• Permission to import of the In-Vitro Diagnostic Reagent “COVID-19 (SARS-COV-2) IgM/IgG ANTIBODY TEST KIT” is refused, until the seroconversion information associated to the product is filed specifying days.