15 April 2019 | News
The focus of the MDiT Forum and Regulation Summit 2019 remains on Regulation, Quality and Technology and renowned speakers will be invited to present compelling topics to attendees
The 15th Exhibition of Medical Device Design & Manufacturing in China (Medtec China 2019) will take place from September 25-27, 2019, at Shanghai World EXPO Exhibition & Convention Center, and the co-located conference — MDiT Forum and Regulation Summit 2019 will be also held at the same time, providing valuable learning opportunities for industry insiders and propelling the development of the medical device industry. The focus of the MDiT Forum and Regulation Summit 2019 remains on Regulation, Quality and Technology and renowned speakers will be invited to present compelling topics to attendees.
Regulation Track aims to provide interpretations on the latest medical regulations and standards in China. What are the implications of regulation updates in 2018 for the medical device industry, and what are the opportunities and challenges for device manufacturers? The answers will be found on site. Experts will also interpret the reform of the Medical Device Clinical Trial Management System, including changes with the catalog of medical devices exempted from clinical trials, and changes in clinical trial requirements for different categories of medical devices.
At Quality Track A: "Total Lifecycle Risk Management for Medical Products", experts will initiate specific discussions on risk management-oriented biological evaluation and testing, risk management in medical device product design and development, how to implement total lifecycle risk management against regulatory inspections upon product launch, and other topics.
Medical device manufacturers that are about to or expected to enter the US market will acquire at the Quality Track B: "Latest MDSAP Developments and FDA Factory Inspection" effective practical experience and case analysis of FDA factory inspection and of using QSIT technology to facilitate FDA on-site inspection.
IIMD (Implantable and Interventional Medical Device)China Summit featured with IIMD exhibits and exhibitors at Medtec China 2019, will initiate discussions on IIMD regulations, market trends, design and material innovation centering on orthopedic implants, cardiovascular intervention products and 3D printing products. Such topics will certainly benefit those who attend the summit.
In addition, there will be a series of high-quality conferences and events free-of-charge, with themes covering medical materials, plastic molding, medical design, electronics, sterilization & packaging, international regulations, and market analysis. Topics will include R&D and technology sharing of transparent film medical dressing, the practical application of flat hot runner technology in medical device manufacturing, updates with ethylene oxide sterilization, the latest R&D of pacemakers and the demand for its core components, and how medical device manufacturers should prepare for MDR and IVDR certifications, The activities aim to explore the application of new technologies under the new situation, and to strengthen upstream and downstream collaboration.