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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..

This is the second in our series of regulatory updates on the EU AI Act. We discussed AIA in our first regulatory update, the EU Artificial Intelligence Act. The EU AIA introduces a comprehensive framework for AI-enabled device regulation in the EU. In this regulatory update we discuss key elements of the regulation and best practices, enforcement and oversight, AI regulatory sandboxes and real-..

We at Emergo by UL are proud to have had one of our senior consultants attend the MedCon Conference in Columbus, Ohio on April 24-26. Here we describe some of our top pre-market consideration takeaways from the conference for those who were unable to make it. We encourage all regulatory professionals to consider attending next year! But if you can’t, no worries. We will report all the medical de..

The Hong Kong (HK) medical device regulatory systemMedical device makers who want to access the Hong Kong market must be aware of the latest regulatory requirements in this special administrative region of China. New developments in Hong Kong’s medical device market include additional leveraged country authorizations and a new digital platform.The HK Medical Device Division (MDD) and the Medic..

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..

The European Commission’s Medical Device Coordinating Group (MDCG) has updated its priorities regarding the In Vitro Diagnostic Medical Devices Regulation (IVDR). The MDCG updated its Joint implementation and preparedness plan for the IVDR to reflect ongoing progress of its work and to set new priorities for the European Regulation (EU) 2017/746 (IVDR). IVDR plan organization The 20-page documen..

Emergo by UL에서 의료기기의 중국 식약처에 제품등록과 관련하여 웨비나를 개최한다. 웨비나는 영어로 진행되며, 신청 후 교육링크는 개별적으로 따로 보내준다. ▶ 일시: 2023년 10월 24일(화) 오전 9시 CDT (한국시간: 10월 24일 저녁 11시) ▶ 교육시간: 1시간 ▶ 신청링크: Medical Device Registration Pathway and Regulatory Requirements in the Chinese Market | Emergo by UL Medical Device Registration Pathway and Regulatory Requirements in the Chinese Market In this complimentary webinar, our experts ..

유럽연합에서 MDR과 IVDR하에서 borderline에 있는 제품의 적용여부와 관련된 문서 개정하여 배포하였다. ▶ 개정일자: 2023년 09월 27일 ▶ Version. 3 ▶ MDR borderlines: medical devices and IVDs medical devices and medicinal products, including advanced therapy medicinal products (ATMPs) medical devices and biocides medical devices and substances of human origin medical devices and cosmetic products medical devices and food medical devices and pe..