의료기기 이야기

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..

한국의료기기산업협회에서 의료기기 제조, 수입업체 대금결제 지연 피해 사례가 있어 이과 관련된 보도자료를 발표하였다. ▶ 의료기관 및 간납업체의 불공정행위에 대응▶ 의료기기 업종 표준유통거래계약서(안)을 마련하고 보건복지부와 공정거래위원회를 통해 제정을 건의할 계획  :: KOREA MEDICAL DEVICES INDUSTRY ASSOCIATION :: (kmdia.or.kr) :: KOREA MEDICAL DEVICES INDUSTRY ASSOCIATION :: www.kmdia.or.kr

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..

A medical device company may have multiple business divisions and device types all working in silos, creating the potential for multiple, seemingly disconnected graphical user interface (GUI) designs and user experiences. Aligning these with a single source of design plans, behaviors and guidelines (i.e., a design system), while taking accessibility and inclusivity into consideration, will aid i..

Historically, the U.S. has been the leader in medical product human factors (HF) engineering maturity with stringent regulatory enforcement, followed by the European Union (EU) with less stringent regulatory enforcement, while most other global regions have had little or no HF guidance or enforcement. However, in the past few years, the global regulatory landscape has continually evolved as othe..