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The start of 2024 has seen a flurry of activity from the UK’s Medicines and Healthcare Regulatory Agency (MHRA) regarding medical device legislation.These updates have greatly increased the UK’s capacity to certify medical devices. Since the publication of the UK regulatory roadmap (January 9), there have been several significant updates to the list of UK-approved bodies for medical devices, inc..

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..

Perhaps you have an idea for a medical device that could revolutionize medical care in the US, or perhaps for an improvement that could increase a device's safety or effectiveness. Bringing an innovative device to the U.S. market can present many challenges but also rewards. The US Food and Drug Administration (FDA) wants to encourage improvements to the overall safety and effectiveness of medic..

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..

The US Food and Drug Administration (FDA) has begun issuing export documents for medical devices in electronic format in order to help streamline processes and reduce time and effort for manufacturers seeking to sell their products in non-US markets. A letter to industry from FDA explains that the agency’s transition to electronic formats took effect January 2, 2024, and applies to documents suc..

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..

Emergo by UL 에서 위험관리 관련하여 웨비나를 진행한다. 유럽에서 개정된 EN ISO 14971:2019+A11:2021에 관한 내용도 포함될 예정이다. ▶ 일자: 2023년 12월 20일(금) 자정 (0시, CST 기준 오전 9시) ▶ 온라인으로 1시간동안 진행 예정 ▶ 링크 Integrated Risk Management Throughout Device Lifecycle | Emergo by UL Integrated Risk Management Throughout Device Lifecycle In this complimentary webinar, our Emergo by UL subject matter expert will outline the latest insights about int..

Emergo by UL 에서 미국 US FDA Pre-Submissions에 대한 웨비나를 진행한다. 최근에 FDA에서 변경된 Pre-submission에 대해 설명하고 각 제조업체에서 준비해야 되는 사항에 대해 설명할 것으로 예상된다. ▶ 일자: 2023년 11월 09일(목) 자정 (0시, CST 기준 오전 9시) ▶ 온라인으로 1시간동안 진행 예정 ▶ 링크: U.S. FDA Pre-Submissions | Emergo by UL U.S. FDA Pre-Submissions In this complimentary webinar, our Emergo by UL subject matter expert will outline the latest insights about U.S. FDA Pre-Submiss..

The RAPS Convergence 2023 concluded on 5 October 2023. For a few glorious days, professionals convened in Montreal, Canada to discuss all aspects regulatory. One topic discussed extensively covered notified bodies and the European Medical Devices Regulation (2017/745, MDR). Notified bodies have been working to harmonize their activities. Notified body representatives have attended meetings and a..

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 ..