Jiangxi Provincial Medical Products Administration Releases Implementation Plan for Medical Device Marketing Authorization Holder System

Today's Rapid Report on the COVID-19 Pandemic in China

1. From 00:00 to 24:00 on November 8, 31 provinces (autonomous regions, municipalities) and the Xinjiang Production and Construction Corps reported 62 new confirmed cases. Among them, 19 cases were imported from overseas, including 4 cases converted from asymptomatic infections; 43 cases were local cases (12 in Hebei, including 11 in Xinzhou City and 1 in Shijiazhuang City; 8 in Heilongjiang, including 7 in Heihe City and 1 in Harbin City; 7 in Sichuan, all in Chengdu City; 5 in Liaoning, all in Dalian City; 4 in Gansu, including 3 in Lanzhou City and 1 in Tianshui City; 3 in Jiangxi, all in Shangrao City; 2 in Henan, both in Zhengzhou City; 2 in Yunnan, both in Dehong Dai and Jingpo Autonomous Prefecture), including 8 cases converted from asymptomatic infections (3 in Gansu, 2 in Henan, 2 in Sichuan, and 1 in Heilongjiang). No new deaths were reported. No new suspected cases were reported. (Source: National Health Commission)

Latest Medical Device News Today

Policy：

▶ Jiangxi Province Drug Administration Issues Implementation Plan for Medical Device Registrant System

New Product：

▶Medtronic Announces Early Clinical Data for Intrepid Transcatheter Mitral Valve Replacement System

Regional Dynamics：

▶ Hubei Plans to Build a "Government-Industry-University-Research-Medicine" Collaborative Innovation Platform to Boost High-Quality Development of the Medical Device Industry

Jiangxi Provincial Drug Administration Issues Implementation Plan for Medical Device Registrant System

Recently, in order to further promote the development of the biomedical industry chain in Jiangxi Province and serve the high-quality development of the medical device industry, the Jiangxi Provincial Medical Products Administration has introduced the "Implementation Plan for the Medical Device Registrant System in Jiangxi Province" (hereinafter referred to as the "Plan") based on the Regulations for the Supervision and Administration of Medical Devices. The Plan strengthens the supervision and management of the registrants’ compliance with obligations related to ensuring the quality of medical devices, post-market sales and services, adverse event monitoring and evaluation of medical devices, and recalls of medical devices. It reinforces the registrants' responsibility for the entire life cycle management of medical devices and their management capabilities across the entire supply chain, while urging the trustees to strictly manage and ensure standardized production. (Source: Jiangxi Provincial Medical Products Administration)

Medtronic Announces Early Clinical Data for Intrepid Transcatheter Mitral Valve Replacement System

On November 6, Medtronic announced clinical data from 15 patients enrolled in the early feasibility study of the Intrepid Transfemoral System at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference. The data showed a 100% survival rate among the 15 patients participating in the clinical study, with no occurrences of stroke or other related symptoms. All implanted patients were free of mitral regurgitation (MR) and other symptoms at the 30-day mark. (Source: PR Newswire)

Hubei Plans to Build a "Government-Industry-University-Research-Medicine" Collaborative Innovation Platform to Boost High-Quality Development of the Medical Device Industry

On November 4, the Hubei Provincial Medical Products Administration held a symposium on the "government-industry-academia-research-clinical" collaborative innovation in medical devices. It was reported that the Hubei Medical Products Administration has formally applied to the National Medical Products Administration to establish the "Center for Medical Device Evaluation, National Medical Products Administration, Hubei Service Station for Medical Device Innovation" in Wuhan. Huazhong University of Science and Technology and Wuhan University have submitted applications to the National Medical Products Administration for the "Research Base for Medical Device Supervision Science, National Medical Products Administration." These initiatives will play a significant and positive role in promoting independent innovation in medical devices and high-quality industrial development in Hubei Province, while also laying the foundation for Hubei to further strive for a national sub-center for drug and medical device evaluation. (Source: Hubei Daily)

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