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As a sequel to our recent update on searches that can be performed in the U.S. FDA 510(k) database, Emergo by UL reports on medical device searches in the European database for medical devices, EUDAMED, with the device registration data that has already voluntarily been included. The European Medical Devices Regulation 2017/745 (MDR) and the European In Vitro Diagnostic Device Regulation 2017/74..

As the end of the calendar year approaches, Brazil’s National Health Surveillance Agency (ANVISA) has released its database on clinical investigations.Background on clinical investigations in BrazilSome medical devices are exempt from ANVISA approval of the study (RDC 837/2023, Article 2 (§ 1º)), including Class  I and II medical devices, IVD clinical performance studies, devices already registe..

Last month the Hong Kong Department of Health delayed release timelines for multiple new features of the Medical Device Information System (MDIS) to September 2024, including electronic submissions for adverse event and safety alert reports. Following a transition period, paper-based submissions are expected to be phased out by the end of the year. Background on MDISThe MDIS is a web-based appli..

We at Emergo by UL would like to point out that the U.S. Food and Drug Administration (FDA) has recently adapted certain searches and information to highlight regulatory guidance for specific medical device types. Medical device and IVD manufacturers who want to stay ahead of regulatory changes to avoid market access disruptions should take note.  Searching FDA guidance documentsThe U.S. FDA  ha..