2023 6月7日 3:00pm JST
ブラジルの国家衛生監督庁（ANVISA）は、2022年9月21日、新しい医療機器規制であるRDC 751/2022を発行しました。新規制は医療機器のリスク分類や、Noｔification及び登録変更要件を含むRegistro、さらにすべてのリスククラスに対する医療機器の表示及び使用説明書の要件を統合・規定しています。今回の規制の更新によって、RDC 185/2001 (classification rules and procedures for Registro – class III and IV medical devices)及びRDC 40/2015 (procedures for Notification and technical dossier – risk class I and II medical devices)は廃止されました。また、新しい規制にはBGMPの適合証明の要件が含まれています。
Emergo by UL Lead Quality & Regulatory Affairs Consultant
IVD製品の設計開発、薬事を含む15年以上の業界経験を有しております。Emergo by ULにおいては、日本での製品上市を目的とした製造販売承認申請やPMDA対面助言の支援を行っています。また、ブラジルの規制に関しては日本企業の新規制理解を深めるためのサポートを行っております。
Contents are prepared by Luiz Levy and Sarah Mundim
Luiz Levy, RAC, manager, Quality and Regulatory Affairs Brazil
Manager, Quality and Regulatory Affairs Brazil, Emergo by UL 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 (U.S., 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, he has peer-reviewed more than 300 regulatory filings and reports, conducted multiple on-site audits on local and foreign manufacturers, 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. Levy 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, Levy held RA/QA positions at CPL Medicals, Goen3, and Medics.
Sarah Mundim, senior Quality and Regulatory Affairs consultant
Quality and regulatory affairs consultant, Emergo by UL 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. Mundim’s background includes compiling and reviewing applications for medical devices of all risk classes for submission to ANVISA; compiling and reviewing marketing submissions per Directive 93/42/EEC and EU Regulation 2017/745 (MDR); compiling and reviewing 510(k) submissions per the U.S. 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, she has peer-reviewed numerous regulatory filings and reports and performed or reviewed more than 400 classifications/technical files of healthcare products. Prior to Emergo, she worked as a QA auditor and then as a study director for Bioagri Pharma, a toxicological test laboratory.