ANVISA published RDC 356/2020 regarding extraordinary and temporary procedures on the requirements for the manufacture, import and acquisition of medical devices identified as priorities by ANVISA due to the international public health emergency resulting from the new Coronavirus.

Our team prepared a few highlights with important changes:

* The manufacture and import of surgical masks, N95, PFF2 or equivalent particulate respirators, goggles, face shields, disposable hospital garments (waterproof and non-waterproof aprons / cloaks), caps and props, valves, respiratory circuits and connections for use in health services, they are exceptionally and temporarily exempt from ANVISA Authorization for Company Operation (AFE), from Notification to ANVISA, as well as from other health authorizations.

* The purchase of new and not yet regularized by ANVISA personal protective equipments, pulmonary ventilators, respiratory circuits, connections and valves, parametric monitors and other medical devices essential to combat the COVID-19 pandemic, by public and private bodies and entities as well as health services, is as long as they have been previously regularized and marketed in a jurisdiction member of the International Medical Device Regulators Forum (IMDRF). It is only  temporarily allowed when similar devices regulated by Anvisa are not available.

Specific requirements that must be met for each device is detailed in the Resolution. The Resolution comes into force immediately and will be valid for 180 days.

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DOMO Salute Team