Brazil: UDI enforced & ANVISA RDC 356/2020 & RDC 379/2020 for Covid-19

RDC 232/2018 - Unique Device Identification (UDI)

UDI will be enforced on 15 June 2020 that require product label with traceability using the bar codes with information including device identifier, expiration date and lot or serial number. The product covered in this enforcement are: Coronary artery stents, and Implants for Hip and knee arthroplasty procedures.

RDC 356/2020 & RDC 379/2020 - Covid 19 Temporary measures

ANVISA (The Brazilian Health Regulatory Agency) has published new regulations related to Covid-19 including the RDC 356/2020 & RDC 379/2020 revision which includes temporary and extraordinary measures for the manufacture and import of products used to combat the pandemic. Some of these new measures include:

Article 9º: It is now possible to market essential medical devices approved in other countries, that are members of the International Medical Device Regulators Forum (IMDRF), in Brazil when there are no similar for sale in Brazil.

The products covered in this article are: personal protective equipment (PPE), pulmonary ventilators, circuits, connections and respiratory valves, parametric monitors and other essential medical devices used to combat Covid-19, new and not regulated by ANVISA.

Those responsible for the importation of IVD kits under the terms of the heading must send, within a maximum period of 5 (five) days, counted from the date of clearance of the shipment, a sample of at least 100 units of each batch imported for analysis by the National Institute for Quality Control - INCQS.

Article 2º: The manufacture and import of products used to combat Covid-19 are exempted from the ANVISA Operation License (AFE), the notification of ANVISA, as well as other health authorizations. However, it is mandatory that companies comply with the other requirements described throughout the RDC.

The products covered by this article are: surgical masks, particulate respirators N95, PFF2 or equivalent, protection glasses, face shields, disposable hospital garments (waterproof and non-waterproof aprons / cloaks), head caps and shoe covers, valves, circuits and respiratory connections.

Source: ANVISA Brazil

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