의료기기 이야기

Why a known problems analysis is crucial for NMPA complianceA known problems analysis (KPA) is a human factors engineering (HFE) activity that aims to identify use issues and user interface flaws with devices currently on the market. Regulators require medical device manufacturers to conduct a KPA to investigate use problems associated with devices that are similar to a device under development ..

BackgroundThe Chief Executive, Dr. Muralitharan Paramasua, of the regulator in Malaysia, the Medical Device Authority (MDA), hosted the 2025 keynote address (January 14).Many programs were presented: e-labeling, UDI, import permit, guidance documents, Medcast 3.0, additional recognized ASEAN countries, and Class A fees. This update focuses on one of the global harmonization/regulatory reliance i..

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 ..

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 ..