Weekly Medical Insights Review Issue 210 (Dec 30 - Jan 3): Regulatory Updates and Product Developments

December 30

December 31

On December 31, the National Medical Products Administration (NMPA) announced a recall notice on its official website. Medtronic (Shanghai) Management Co., Ltd. reported that due to the potential for cracks or leaks caused by over-tightening of the three-way valve, which could lead to infection, the manufacturer, Medtronic Inc., initiated a voluntary recall of its external drainage and monitoring systems (registration numbers: Guo Xi Zhu Jin 20163145109 and Guo Xi Zhu Jin 20163665109). The recall is classified as a Level 1 recall. (National Medical Products Administration)

02. Shanghai Municipal Drug Administration Issues the "Implementation Plan for Regulating Enterprise-related Administrative Inspections by Shanghai Drug Regulatory Authorities"

On December 31, the Shanghai Municipal Drug Administration issued the "Implementation Plan for Regulating Enterprise-related Administrative Inspections by Shanghai Drug Regulatory Authorities." Objectives: Focusing on issues such as "arbitrary inspections, repeated inspections, and multi-agency inspections," while strictly maintaining drug safety standards and ensuring effective regulation, adhere to the principles of legally defined authority, fairness, scientific efficiency, and combining inspection with guidance. The aim is to reduce the number of on-site inspection targets and enhance inspection relevance, decrease the frequency of on-site inspections and improve their effectiveness, streamline on-site inspection content and increase precision, minimize the impact of inspections on enterprises, and improve regulatory standardization. This will promote a shift in drug regulation towards service-oriented, preventive, and digital intelligent governance. Within 2-3 years, the goal is to significantly reduce the number of planned enterprise-related on-site inspections, while enhancing both the quality and efficiency of inspections and the level of satisfaction among enterprises. (Shanghai Municipal Drug Administration)

Starting from January 1, 03, 45 types of consumables will be reduced in price.

Recently, the Hebei Provincial Medical Drug and Device Centralized Procurement Center issued the "Notice on Preparing for the Implementation of the Second Procurement Year for the Selected Results of 45 Types of Medical Consumables Including Dry Medical Film" (hereinafter referred to as the "Notice"). According to the Notice, the selected results for 19 types of consumables including dry medical film from the Sanming Alliance and 26 types of liver function biochemical test reagents from the Jiangxi Alliance will be implemented in Hebei Province starting January 1, 2025. (Medical Device Dealers Alliance)

January 2

01.Shanghai's Optimization of the Reform Pilot for the Review and Approval Process of Drug Supplemental Applications Shows Initial Results

In November this year, Shanghai was approved by the National Medical Products Administration (NMPA) to become one of the first 10 provinces in China to carry out the pilot reform of optimizing the supplementary application review and approval process for pharmaceuticals. On December 30, the supplementary application for isoleucine submitted by Shanghai Union Amino Acid Co., Ltd., the first pilot product in Shanghai, was officially approved. This makes it one of the first products nationwide to be approved through the optimized procedure under the reform pilot program, marking initial success in Shanghai's efforts within this pilot initiative. This step once again demonstrates solid progress in supporting the high-quality development of Shanghai’s biopharmaceuticals industry. (Shanghai Municipal Medical Products Administration)

02. The Joint Research Project in the Beijing-Tianjin-Hebei Region Successfully Concludes, Promoting High-Quality Development of Traditional Chinese Medical Devices

According to the relevant requirements of the "2024 Key Work Points for the Coordinated Development of Drug Regulation in the Beijing-Tianjin-Hebei Region," the Beijing Medical Device Evaluation and Inspection Center, the Tianjin Medical Device Evaluation and Inspection Center, and the Hebei Medical Device Technical Evaluation Center jointly held the concluding meeting of the research project on "Clinical Evaluation Requirements and Product Scope Descriptions for Class II Traditional Chinese Medicine (TCM) Medical Devices" in Beijing. The research team presented the background, research process, and findings of the project. Attendees engaged in an in-depth discussion of the research report and the "Key Points for Clinical Evaluation Review of Class II TCM Medical Devices," offering valuable suggestions and opinions. These included fundamental principles of clinical evaluation, the application of TCM’s holistic concept, understanding human experience, and methods for calculating sample sizes in clinical trials of pulse diagnosis devices. Moving forward, the research team will further refine the results based on the feedback received, aiming to address the mismatch between the clinical evaluation methods and scope of application for Class II TCM medical devices and the existing Western medicine evaluation system. This work will provide a reference for TCM medical device registration applicants and technical review personnel while also supporting the standardized development and scientific regulation of TCM medical devices in the Beijing-Tianjin-Hebei region. (Beijing Municipal Drug Administration)

January 3

01.Optics Valley Medical Device Innovation Service Center Officially Inaugurated

Recently, the Optics Valley Medical Device Innovation Service Center was officially inaugurated. The Optics Valley Liaison Office of the Hubei Service Station for Medical Device Innovation of the Center for Medical Device Evaluation, National Medical Products Administration, was also granted its plaque at the same time. It is reported that the Optics Valley Medical Device Innovation Service Center will link, gather, and integrate various elements of each segment in the medical device innovation chain and industry chain, providing a full range of services to medical device companies including R&D design, registration testing, clinical research, registration application, and mass production services. The aim is to "concentrate superior resources, assemble advanced forces, and gather professional services" to promote the rapid development of the industry. The center will adopt an "online + offline" service model. The online portal is scheduled to go live in the first quarter of 2025, enabling service applications, demand handling, project tracking, and outcome evaluation, allowing companies to have a clear understanding of the service content and progress. (CNR Network)

02. National Oral Medicine Center Forms 12 Specialty Alliances to Enhance Oral Medical Services

Recently, seven specialized alliances in oral pathology, oral medical imaging, pediatric dentistry, preventive dentistry, oral mucosal diseases, orthodontics, and general dentistry have been officially established. As of now, all 12 specialized alliances under the National Center for Stomatology have been fully formed. This will further enhance the accessibility and equity of oral medical services. Oral health is an important indicator reflecting public health standards. To quickly address the shortcomings and weaknesses in the development of stomatology and lead its advancement, at the end of 2020, the National Health Commission approved the establishment of the National Center for Stomatology, comprising Peking University School of Stomatology, West China Hospital of Stomatology, Sichuan University, and the Ninth People's Hospital affiliated with Shanghai Jiao Tong University School of Medicine. (Xinhua News Agency)

03. Shanghai: Support for innovative exploration in cutting-edge medical fields such as brain science and brain-computer interfaces, computational biologyShanghai Releases Development Plan for Medical Artificial Intelligence, Supporting Innovation in Frontier Areas such as Brain Science, Brain-Computer Interfaces, and Computational Biology, Strengthening Institutional Collaboration, Promoting Core Algorithm Technology R&D, Building Platforms for Innovative Drug Screening Optimization and Large Biomedical Model Design, Accelerating Product R&D. (Bioon.com)

Derived from Pengpai

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