LATEST NEWS

ANVISA published last friday (March 19th) 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 [...]

At the end of 2020 INMETRO published Ordinance 384, which came into force on December 28th. The new regulation replaces Ordinance 54/2016 with new requirements for conformity assessment for equipment under health surveillance, establishing more clearly the competence of Certfication Bodies and ANVISA. Amongst the main changes, we highlight: [...]

ANVISA published, on the 9th of October, Technical Note nº 218/2020 updating the list of products that are exempt from regulation by the Agency. Some of these products were included in the list of low risk health products (class I) subject to registration. However, considering that they did not fit the definition of medical devices... Leia [...]

ANVISA published today (September 18th) the Resolution 423/2020 which establishes that Risk Class II medical devices that were previously under the CADASTRO regime, will be now taking the NOTIFICATION route. Last year (March 1st) ANVISA had established the NOTIFICATION route for Risk Class I devices through RDC 270/2019. Under the new [...]

In tackling the Covid-19 pandemic ANVISA has been focusing on the transparency of data, and recently made available for consultation, through Business Intelligence (BI) platforms, the results from monitoring Covid-19 related products and diagnostic tests. One of the platforms is the Post-Market Monitoring of the quality of Covid-19 related [...]

ANVISA published yesterday (September 3rd) RDC 419/2020 extending the validity of the RDC 346/2020 which defines extraordinary and temporary criteria and procedures for GMP Certification, for  registration purposes and post-registration changes to active pharmaceutical ingredients, medicines and medical devices, due to the international public [...]

From April this year, ANVISA implemented new rules for the classification of petitions for the alteration of medical devices. According to ANVISA, the measures, ruled by RDC 340/2020 and IN 61/2020, aim to define different categories for alterations on medical devices based on their risk, making clear which changes have to be previously [...]

ANVISA has made available on their website the annual Management Report, concerning 2019’s results and the governance of the Agency. The report aims to make available to the society general data and specific information from technical departments. The report shows that the Agency has achieved good results and an increasing number of medical [...]

Medical device manufacturers are providing life-saving equipment to care for patients who have been infected with the new coronavirus. But how do you conduct a third-party audit, required for market access, when most of us must work remotely? How the Brazilian Regulatory Agencies such as ANVISA and INMETRO are dealing with this? Remote [...]