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Brazilian medical device regulator ANVISA has published new legislation allowing manufacturers of higher-risk devices to leverage registrations from some foreign regulatory authorities when applying for market access in Brazil. According to the new Reliance route which started June 3, ANVISA will now rely on the decisions of authorities from other jurisdictions, but remains independent and respo..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 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 ..

Brazilian medical device regulator ANVISA has published new legislation allowing manufacturers of higher-risk devices to leverage registrations from some foreign regulatory authorities when applying for market access in Brazil. Background to RDC 741/2022 and September 2023 consultation ANVISA announced RDC 741/2022 (August 10, 2022) to establish a resolution to leverage registrations from foreig..

As previously reported by Emergo by UL, Brazilian medical device and IVD market regulator ANVISA has released three guidance documents to further clarify Resolution RDC 830/2023. Of interest to this post is the document regarding IVDs with a changed risk classification. The IVDs are presented in five tables: Class III to Class II, Class II to Class III, Class IV to III, Class II to IV, and Class..