LATEST NEWS

In response to the COVID-19 outbreak, Brazilian regulatory agencies (ANVISA & INMETRO), as well as many other regulators around the world, have released in the past month Ordinances and Resolutions regarding emergency and temporary procedures for medical devices that are strategic to fight against the pandemic. The regulations include new [...]

Updated on July 2nd 2020: INMETRO published, on the 30th of June, Ordinance nº 225 which extended the terms and temporary procedures for Conformity Assessments, due to the international public health emergency resulting from the new Coronavirus. The Ordinance extends the possibility of remote audits until December 31st 2020, as well as [...]

ANVISA published RDC 356/2020 regarding extraordinary and temporary procedures on the requirements for the manufacture, import and acquisition of medical devices identified as priorities by ANVISA due to the international public health emergency resulting from the new Coronavirus. Our team prepared a few highlights with important changes: * [...]

ANVISA published yesterday RDC 349/2020 regarding temporary procedures for requests for the regularization of personal protective equipments, pulmonary ventilator medical equipments and other medical devices identified as strategic by ANVISA due to the international public health emergency resulting from the new Coronavirus. Our team prepared [...]

Covid-19: Prioritizing IVD products Last Thursday (03/12/2020) ANVISA published an update regarding IVD products for Covid-19 diagnosis aiming to speed products regularization and the offer of diagnostics. ANVISA will prioritize the analysis of all processes related to products for Covid-19 diagnosis and other agents that cause respiratory [...]

Published on Tuesday (11) in the Federal Official Gazette, Normative Instruction 10 from the Ministry of Economy reduced the barriers to the presence of external companies in federal bids. The new rules will take effect on May 11, 2020. According to the Normative Instruction, foreign companies must open a National Corporate Taxpayer Registry [...]

The Medical Device Single Audit Program (MDSAP) is a program developed by IMDRF (International Medical Device Regulators Forum) that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing [...]

ANVISA published in January the SaMD Regulatory Impact Analysis Report regarding important information for the safe and effective use of medical softwares as well as the sanitary actions associated with these products . According to the Agency, traditional regulations for medical devices have a gap, as they do not cover specific aspects for [...]

ANVISA published last December three Guides from the International Medical Device Regulators Forum (IMDRF), related to the scenario of clinical evaluation of medical devices in Brazil. The Guides express ANVISA’s understanding of best practices regarding procedures, routines and methods deemed appropriate to meet technical or [...]