Date & Time
Feb 14, 2023 8:00am CST China
9:00am CST China
The Brazilian Health Regulatory Agency (ANVISA) issued the new medical device regulation RDC No. 751/2022 on Sept. 21, 2022. The new RDC consolidates medical device risk classification, the Notification and Registro regimes (including registration modification requirements), and the requirements for medical devices’ labeling and instructions for use for all risk classes. This update revokes RDC 185/2001 (classification rules and procedures for Registro – class III and IV medical devices) and RDC 40/2015 (procedures for Notification and technical dossier – risk class I and II medical devices). The new resolution also includes the requirements for Brazilian Good Manufacturing Practices’ (B-GMP) proof of compliance. In this webinar, the presenters will help attendees develop a greater understanding of the new requirements introduced by RDC 751/2022, and the decision points they might face when the regulation becomes effective, on March 1, 2023. The presenters will also share practical information intended to equip manufacturers for future medical device marketing submissions.
Luiz Levy, RAC, manager, Quality and Regulatory Affairs Brazil
Luiz Levy is located in São Paulo, Brazil, and has over ten years of medical device industry experience, primarily focused on high-risk devices, including implantable devices, electrical medical equipment and disposables subject to INMETRO Certification. Luiz’s background includes: implementing and auditing quality systems to B-GMP Regulation RDC 665/2022, ISO 13485:2016 , Directive 93/42/EEC, EU Regulation 2017/745 (MDR), FDA 21 CFR 807, FDA QSR 21 CFR 820, MDSAP-Medical device Single audit program; performing multiple local and foreign (US, Europe, Japan) audits to prepare companies for ANVISA inspections; assisting companies during ANVISA inspections; compiling medical device and IVD applications; clinical data review; and compiling and peer reviewing market access reports. As Manager, Quality and Regulatory Affairs, Luiz has peer reviewed more than 300 regulatory filings and reports, conducted multiple on-site audits on local and foreign manufactures, performed internal audits, and performed or reviewed more than 400 classifications/technical files of healthcare products. He also contributed to the final draft of new ANVISA (RDC) regulations during a series of strategic meetings with the Agency. Luiz is the designated Health Manager for Emergo’s Brazil Registration Holder services, and he additionally manages Emergo Brazil’s RDC 665/2022 quality system. Prior to Emergo, Luiz held RA/QA positions at CPL Medicals, Goen3, and Medics.
Sarah Mundim, senior Quality and Regulatory Affairs consultant
Sarah Mundim is located in Brasília, Brazil, and has over ten years of medical device industry experience, from low risk to high-risk devices, including implantable devices, disposables and electrical medical equipment subject to INMETRO Certification. Sarah’s background includes: compiling and reviewing applications for medical devices of all risk classes for submission to ANVISA; compiling and reviewing marketing submissions per the Directive 93/42/EEC and EU Regulation 2017/745 (MDR); compiling and reviewing 510(k) submissions per the US FDA requirements; reviewing clinical data and compiling Clinical Evaluation Reports per the EU MDR requirements; and compiling and peer reviewing multi-market research reports. As a consultant, Sarah has peer reviewed numerous regulatory filings and reports, and performed or reviewed more than 400 classifications/technical files of healthcare products. Prior to Emergo, Sarah worked as a QA Auditor and then as a Study Director for Bioagri Pharma, a toxicological test laboratory.