COVID-19: ANVISA reduces requirements for PPE and medical equipment
The Brazilian Ministry of Health and the Brazilian Health Regulatory Agency (ANVISA) have simplified for six months the requirements for manufacturing, importing and purchasing priority medical devices for use in the context of combating the Coronavirus Pandemic by a normative issued on March 23, 2020. The products covered by the new rules include personal protection equipment (PPE) such as surgical masks, glasses protective gloves, face shields, as well as N95 respirators, PFF2 or equivalent and disposable hospital garments (waterproof and non-waterproof aprons / cloaks).
Until September, 2020, the manufacturing, importing and purchasing of these products will no longer need any previous sanitarian authorization or certification given by ANVISA. New items not regulated by ANVISA may be imported or purchased as long as they are regulated and commercialized in a jurisdiction member of the International Medical Device Regulators Forum (IMDRF).
However, for producers based in Brazil, the following minimum requirements to fabricate surgical masks apply. New manufactured surgical masks:
- Must be made of non-woven material for dental-medical-hospital use;
- Must have at least one internal layer and one external layer and, obligatorily, a filtering element (in a consolidated form or not), in order to meet the requirements established in the technical standards established by ABNT NBR 15052:2004 and ABNT NBR 14873:2002.
These normative resolutions directly impact trade of fundamental goods in COVID-19 context since they create mechanisms to facilitate trade regarding imports of goods by Brazil. Thus, it is expected that there will be an effective customs clearance and greater speed in accessing orders from abroad.