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Completing the process of reviewing and consolidating normative acts that allowed improvements in the wording and form of normative acts and the exclusion of obsolete provisions, ANVISA published on March 30th 2022, in the Brazilian Official Gazette (D.O.U., in Portuguese), RDC No. 665/2022, which provides for Good Manufacturing Practices [...]

Aiming to keep up with the scientific and technological advances and meet new demands from the health care sector, ANVISA published – on the 30th of March 2022 – RDC 657/2022 which provides for the regularization of Software as a Medical Device (SaMD). The Resolution will come into force on the 1st of July 2022.... Leia mais »

Throughout RDC 595/2022, ANVISA has established on the 28th of January the requirements for SARS-CoV-2 antigen self-test’s registration, distribution, commercialization and usage. The Resolution allows pharmacies and other healthcare companies to sell COVID-19 self-test kits directly to the population. Here are a few highlights on the [...]

On January 10th 2022, the regulation that provides for the identification of medical devices regularized by ANVISA through the Unique Device Identification (UDI) system – RDC 591/2021 came into force. The Unique Devices Identification is an international standard that complies with the International Medical Device Regulators Forum’s [...]

– all import processes must comply with RDC 81/2008 On the 18th 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 [...]

The deadline for uploading the medical devices’ instructions for use on ANVISA’s portal ends at the end of this month. Resolution RDC No. 431/2020, which came into force on November 1st 2020, granted a period of 1 year to make registered devices’ instructions for use available, for products which were approved by ANVISA before the... Leia [...]

25 Collegiate Board Resolutions (RDCs) and one Normative Instruction (IN) that were published by ANVISA on 08/31/2021 came into force on October 1st, 2021. The publications are part of the 4th stage of the review and consolidation process of the Agency’s normative acts, in compliance with Decree 10,139 / 2019 – known as the [...]

On June 1st 2021 the new RGCP (General Product Certification Requirements) came into effect, as established by INMETRO Ordinance No. 200 (April 29th, 2021). The new requirements are a part of INMETRO’s project to reduce the certification processes’ bureaucracy in the Brazilian market, and revoked previous Ordinances numbers 118-2015, 250-2016; [...]

The Brazilian Health Regulatory Agency – ANVISA – released on March 5th the report Regulation in Numbers, presenting the 2020 actions aiming to improve the regulatory quality of the Agency. The report summarizes the main activities of the year, such as general and normative publications, regulatory projects, community participation [...]