ANVISA published last friday (March 19^th) RDC Nº 483/2021, which defines extraordinary and temporary requirements for the import of medical devices identified as priority by ANVISA due to the international public health emergency resulting from the new Coronavirus.

Under the terms of the new Resolution, medical devices listed in Annex I of the Resolution may be imported on an exceptional and temporary basis by public and private bodies and entities, including health establishments and services, and are exempted from sanitary regulation by ANVISA.

Devices such as patient ventilator equipment, oximeter, patient monitor, infrared thermometer, among others listed on the World Health Organization’s (WHO) priority list, can be imported since they meet the criteria of the Resolution, such as presenting a proof of pre-qualification by WHO or a valid Registration in a country member of the International Medical Devices Regulators Forum – IMDRF. In addition, a proof of compliance with the Good Manufacturing Practices in the origin country, or equivalent, must be presented.

The importer must guarantee their origin, quality, safety and effectiveness, carry out post-market monitoring, guaranteeing the traceability, and comply with the applicable regulation.

In addition, while the Resolution is in force, the strategic medical devices in fighting the pandemic listed in the Regulation may be imported with packaging, labels and package inserts according to the standards and language established by the foreign health authority responsible for approving their regularization. It will be up to the importer to adopt risk mitigation actions considering the differences in information and formats between the original packaging, labels and package inserts in comparison with the national regulatory guidelines.

However, when important for the correct use of the product, the importer shall provide labels and instructions for use in Portuguese. The importer must also make public that the product has not been evaluated by Anvisa regarding the criteria of quality, efficacy and safety, and that the product is approved by a foreign health regulatory authority.

Moreover, the new Resolution extended by one year the validity of medical device’s registrations granted in accordance with RDC nº 349/2020 (Temporary procedures for personal protective equipments, pulmonary ventilators and strategic medical devices).

The alternative and temporary procedures described in the Resolution will be valid for 60 (sixty) days and may be renewed for equal and successive periods, and comes into force since the publication date.

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team