广东江门宣贯新修订医疗器械GMP

Core Insights - The article discusses the organization of an online and offline training session by the Jiangmen Market Supervision Administration in Guangdong Province, focusing on the newly revised Medical Device Good Manufacturing Practice (GMP) [1] - The training aims to enhance compliance management and regulatory enforcement capabilities among regulatory personnel and company representatives [1] Group 1: Training and Implementation - The training emphasizes the core requirements of the Medical Device GMP, highlighting the background of the revisions, major changes, and key implementation points [1] - The session aims to provide a clear understanding of the five major highlights of the Medical Device GMP through accessible explanations [1] Group 2: Ongoing Support and Supervision - The Jiangmen Market Supervision Administration plans to continue its efforts in promoting the Medical Device GMP through regular, tiered training and guidance [1] - There will be targeted support for key positions in research and development, production, and quality management within companies [1] - The administration will incorporate the implementation of Medical Device GMP into daily regulatory activities, focusing on high-risk products and companies with weak quality management [1]