– all import processes must comply with RDC 81/2008

On the 18^th of November ANVISA informed that Resolution RDC 483/2021 was not extended. The Resolution, originally published in March this year, defined 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.

During the term of the Resolution, medical devices that fit the criteria were allowed to be imported on exceptional and temporary basis, and were exempted from sanitary regulation by ANVISA.

In addition, while the Resolution was in force, the strategic medical devices in fighting the pandemic listed in the Regulation could 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.

This Resolution – which losts its effects on November 13th – also 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). However, medical device’s registrations granted under the terms of RDC 349/2020 and which validity were extended by RDC 483/2021 will not be affected – they remain with 2 year valitidy since approval. After their expiration, a new registration under regular process will be requested before ANVISA in order to keep the medical device commercialization in Brazil.

According to ANVISA “It is worth noting that entities from the productive sector and technical areas of the Agency understand that the consumption-demand ratio of medicines and health products regulated in Brazil is once again balanced.” ANVISA also reitarates its commitment to remain alert and vigilant to adopt appropriate measures if necessary.

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DOMO Salute Team