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The New Zealand (NZ) Associate Minister of Health announced the intent to repeal the Therapeutic Products Act 2023 (TPA), which otherwise would come into force this year, with most provisions taking effect on September 1, 2026. On May 23, the Associate Minister also released a lightly redacted Cabinet paper and decision meeting minutes outlining the rationale behind the Ministry decision. Develo..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: Medical Device Software and Cybersecurity▶ 일시: 2024년 05월 14일 CST 10시 (한국시간: 05월 14일 23시)  As medical devices become more and more interconnected — and the applications of medical device software grow exponentially — there is a need to ensure that these devices, when placed on the market, are safe and effective and remain in this state throughout their lifetime. I..

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 ..

Safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) shall be performed in line with the requirements of Article 76(2) of Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation (IVDR): The sponsor shall report without delay to all Member States in which a performance study is being conducted all of the following by means of the electronic system..

The first deadline for Regulation 2023/607 is rapidly approaching. Manufacturers of legacy medical devices sold in the EU market will receive a regulatory reprieve when Regulation 2023/607 System and Procedure Packs goes into effect May 26, as long as certain conditions are met. About Regulation 2023/607 We briefly share again the requirements for Regulation 2023/607 amending the European Medica..

Emergo by UL 에서 MDR 관련하여 최근에 발표한 Regulation (EU) 2023/607과 관련된 내용으로 웨비나를 진행한다. ▶ 일자: 2024년 01월 18일(목) 자정 (0시, CST 기준 오전 9시) ▶ 온라인으로 45분 동안 진행 예정 ▶ 링크 Regulation EU 2023/607 Frequently Found Issues | Emergo by UL Regulation EU 2023/607 Frequently Found Issues In this complimentary webinar, our Emergo by UL subject matter expert will outline the latest insights about Regulation EU 2023/607. www.em..

[Introduction] This document presents questions and answers on requirements related to importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The term ‘devices’ will be understood to include medical devices, accessories for medical devices, products listed in Annex XVI of the MDR, in vitro dia..