LATEST NEWS

  In order to approve and update the list of Technical Standards equipment under Health Surveillance must comply with, ANVISA published last November the Normative Instruction number 49, which came into effect immediately after the publication (22nd November 2019). It is important to highlight that Normative Instructions No. 4  (September [...]

  Updates regarding Definitions, Classification, Registration Pathways, Labeling and Instructions for Use requirements for Medical Devices and IVD Medical Devices   ANVISA has opened in last October the Public Consultation 730/2019 to discuss with the community updating RDC 185/2001, the standard that drives medical device [...]

We are proud to participate once again the world’s largest event for the medical sector – MEDICA 2019 – from November 18th to November 21st in Düsseldorf, Germany. We’ll be at MEDICA 2019 to talk about how we’re helping medical device companies bring to market new products to Brazil, and discuss the key areas of... Leia mais »

Our team has compiled a few important news from the past days concerning medical device’s regulation and the Brazilian regulatory system: ANATEL – New regulation for Conformity Assessment and Homologation of Telecommunication Products ANATEL approved on October 17th, the new Regulations for Conformity Assessment and Homologation of [...]

ANVISA, the Ministry of Economy and the Presidency approved, on Wednesday (9/10), the Agency’s Digital Plan. As a part of the strategy to implement the Executive Power’s Digital Governance Policy, the program wishes to transform 120 ANVISA services to digital by the end of 2020. Throughout 2019 we have had significant progress [...]

Brazilian medical device market regulator ANVISA published on September 24th new rules for manufacturing, importing, marketing and vigilance responsibilities concerning custom-made devices. Under ANVISA’s current system, custom-made devices’ applications had to go through a specialized submission process, with no specific Brazilian regulations [...]

ANVISA recently opened a new communication channel and our team prepared an update on all the available resources for contacting Brazilian key Regulatory Agencies, concerning medical devices. Knowing how to reach out to the agencies can help if you intend on entering the Brazilian Market. ANVISA Central de Atendimento / Call Center The phone [...]

ANVISA publishes 2018 management results Brazilian medical device market regulator ANVISA recently published the annual Management Report concerning 2018’s results. According to Willian Dib, ANVISA’s CEO, presenting the annual report to the society reaffirms the Agency’s commitment and transparency. DOMO’s Team has evaluated the report and [...]

ANVISA has published the second trimestral GGTPS (Medical Device Technology General Management) performance report. The report presents data, results and metrics concerning the first two trimesters of 2019. The first report, published ion April, can be found on ANVISA’s website. According to Leandro Rodrigues Pereira, General Manager of the [...]