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BackgroundFollowing the publication of the draft PMS SI on the World Trade Organization (WTO) website on July 26, 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) has, after considering stakeholder responses to that draft, published the “final” draft PMS SI. This instrument introduces new PMS requirements for medical devices that improve patient safety by establishing stricte..

You might have heard some rumors already: Several European parliamentarians sent a joint motion for resolution to the European Commission (EC). On October 21st, 2024, a European Parliament resolution “on the urgent need to revise the Medical Devices Regulation” (2024/2849(RSP)) was submitted to the EC. In addition, the Heads of Medicines Agencies (HMA, heads of EU Competent Authorities responsib..

BackgroundIn recent years, the TGA has enacted several reforms to advance regulatory harmonization or reliance. Manufacturers are able to leverage existing conformity assessment evidence issued by a comparable overseas regulator or assessment body as the Manufacturer Evidence to support an application to add a medical device or IVD to the Australian Register of Therapeutic Goods (ARTG). Further ..

Background on post-market surveillance globallyPMS has been a pivotal topic. The European regulations (Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/746, IVDR)) officially defined the term PMS (Article 2(60)). In 2019, the U.S. FDA introduced the term Total Product Life Cycle (TPLC) as a "holistic” perspective with the FDA throughout the entire lifec..

We present our insights from the past quarter. Advances in regulatory harmonization, as shared after the first three months and second three months of the year, continue. While it may have been a summer break for many, regulatory developments abound. This update features regulatory harmonization and a number of global developments revolving around Unique Device Identifiers (UDI). Word of the day..

Overview of Threshold Analyses for Combination ProductsThreshold analyses help determine if differences related to external critical design attributes lead to additional use-related risks to the end user when comparing a proposed generic product to a reference product. The methodology for threshold analyses is described by the U.S. Food and Drug Administration (FDA) draft guidance document relea..

Emergo by UL presented some of the elements to consider as part of the regulatory strategy: market and sales potential, reimbursement possibilities, academic and physician interest, and the regulatory system, including global harmonization or reliance. We use the example of South Korea where because of the public healthcare system (95% universal public healthcare system, 1989 National Health Ins..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: Regulation (EU) 2024/1860 and IVDR Compliance in Europe▶ 일시: 2024년 10월 16일 CST 9시 (한국시간: 10월 16일 23시)  Are you an IVD medical device manufacturer who needs a better understanding of what action you will need to take and when so that you can make use of the extension under the revised Regulation (EU) 2024/1860. The European Commission amended the In Vitro Diagnost..

BackgroundIn China, a series of State Orders have been promulgated to establish the legislative basis for medical device requirements. The current State Order is State Council Order No. 739, Regulations for the Supervision and Administration of Medical Devices.The NMPA has published a draft Medical Device Management Law (Aug. 28,) for public comment.  Proposed Medical Device Legislative Changes ..

While it was a whirlwind of less than 25 minutes for five lofty learning objectives on global regulatory strategy, we felt all the topics were seminal. A synopsis of one part of our presentation follows. The importance of a well-defined intended purpose and indications for useAs we continue to observe issues related to the intended purpose/use and indications for use, we emphasized the importanc..