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BackgroundMedical device manufacturers must conduct appropriate testing to demonstrate that their devices are appropriately safe and effective before sale in the US. In many cases some animal and/or microorganism testing, such as to demonstrate biocompatibility, is required to obtain U.S market authorization.In February 2024, the U.S. Food and Drug Administration (FDA) noted concern that some th..

On September 18, Robert Reid, Ph.D. Deputy Director, Innovative Devices at the Medicines and Healthcare products Regulatory Agency (MHRA), updated the RAPS audience on the current status of the UK legislation. To our knowledge, this is one of the most recent updates from the MHRA. The first half of 2024In January 2024, the MHRA shared a roadmap for 2024-2025. The roadmap proposed regulatory refo..

Returning from a long holiday and need to catch up on EU medical device and IVD regulatory developments? Read our update on European regulatory news over the last few months. Amending legislation published to extend the transition of legacy IVDs and roll out EUDAMEDRegulation 2024/1860 was officially released to extend the transition time for legacy IVDs, roll out EUDAMED, and require data on di..

We last wrote about the U.S. FDA eSTAR when it became compulsory for 510(k)s. At the time, the eSTAR was voluntary for De Novos. Background on De NovosThe De Novo Classification Request “De Novo” is the regulatory mechanism used when manufacturers have a novel medical device that they expect is not high risk and so should be Class II (special controls and general controls) or Class I (general co..

In its August 22 webinar, the U.S. Food and Drug Administration (FDA) discussed the Stage 1 requirements imposed on laboratory-developed test (LDT) manufacturers.U.S. FDA Final Rule on LDTsLDTs are in vitro diagnostic devices (IVDs) that are designed, manufactured and used within a single clinical laboratory and were placed under enforcement discretion in 1976 with the medical device amendments ..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: Importer/Distributor MDR Requirements and Impacts for Manufacturers▶ 일시: 2024년 09월 11일 CST 09시 (한국시간: 09월 11일 23시)  Economic Operator (EO) is a term not identified in the Medical Devices Directive 93/42/EEC (MDD). The Medical Devices Regulation (EU) 2017/745 (MDR) defines in Article 2 what an EO is. There are four types of entities/organizations: manufacturer, au..

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..

Our second post on the new draft of the NOM for Medical Device Good Manufacturing Practices (GMP), PROY-NOM-241-SSA1-2024, discusses relevant updates concerning the restructure of content and key changes over the requirements for manufacturers, conditioners, and distributors of medical devices in Mexico. Reorganization of PROY-NOM-241-SSA1-2024This new draft contains several structural changes t..

Background on NOM-240-SSA1-2024The regulator in Mexico, COFEPRIS, released on July 24, 2024, a new draft for the NOM for Medical Device Technovigilance, PROY-NOM-240-SSA1-2024. This update follows a trend of recent revisions over Mexican Standards (Emergo reported on PROY-NOM-137-SSA1-2024, Medical Device Labeling). The current version of NOM-240 was published in 2012, so an update was overdue t..