[Emergo, UL] Webinar: Revised IVD Regulation RDC 830/2023

Emergo에서 아래와 같이 웨비나를 개최한다.

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▶ 주제: Revised IVD Regulation RDC 830/2023

▶ 일시: 2024년 04월 30일 CST 9시 (한국시간: 04월 30일 23시)

 

 

The ANVISA – Agência Nacional de Vigilância Sanitária  issued Resolution RDC No. 830/2023, on Dec. 11, 2023. The resolution is intended to help IVD medical device manufacturers determine what information is required in a registration submission. The Resolution outlines a new road map that focuses on sanitary classification, notification and registro applications and labeling requirements.

 

In this webinar, the presenters/presenter will help attendees develop a greater understanding of the decision points they might face when determining a submission category and will examine the examples provided by the ANVISA. The presenters will also discuss the evaluation information the ANVISA suggests providing for each category and will share practical information intended to equip manufacturers for future medical device marketing submissions.

 

 

Revised IVD Regulation RDC 830/2023 | Emergo by UL

Revised IVD Regulation RDC 830/2023

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