Speakers from SFDA and CCCMHPIE attend Medtec China 2017 to explore regulatory updates in China, the US and the EU
The “MDiT Forum and Regulation Summit 2017” is always concerned with Regulations, Quality and Technology and presenters will continue to focus on these very three themes. The “Regulation Track A: Chinese Regulatory Updates and Compliance” event has invited Hong Qian, the chief reviewer of Medical Device Registration Department of Shanghai Food and Drug Administration Certification and Evaluation Center, to present on the medical device industry status and the regulation updates; The “Regulation Track B—Situation Analysis of Medical Device Foreign Trade and Overseas Market Access Strategy” event will be convened by the CHINA CHAMBER OF COMMERCE OF MEDICINES & HEALTH PRODUCTS IMPORTERS & EXPORTERS as co-organizer. Tianzhi Cai, Deputy Secretary-General and Director of Medical Devices Division, will give a speech about Analysis on the Overall Situation of Import and Export of Medical Devices and Analysis of Main Foreign Trade. The NAMSA BPMDS Symposium will continue to invite experts from NAMSA, the world’s leading medical device testing and consulting firm, to analyse the latest changes of regulations and implementation progress in the European and American markets.
FDA officer in first official introduction about MDSAP at Medtec China
The Medical Device Single Audit Program (MDSAP) was officially implemented in January this year jointly by regulatory agencies from the United States, Australia, Brazil, Canada and Japan. By participating in the MDSAP pilot project, medical device manufacturers are able to enter multiple markets with a single Inspection. Currently, the U.S. Food and Drug Administration has not yet explained the project widely in China, however as one of the key projects supported by the FDA, William M. Sutton (FDA Assistant Country Director of China) has been invited to introduce issues related to MDSAP and QMS Improvement at the Quality Track of the MDiT Forum and Regulation Summit 2017. He will also offer Q & A opportunities in a special spot.
Medtec China 2016 onsite conference
Two technical conferences in strong return; focus on implantable and interventional medical devices and medical combination
The 6th IIMD China Summit (Implantable and Interventional Medical Device) takes place again this year. Topics includes: Import substitution process for interventional medical devices and development analysis of main product; Natural polymer materials for orthopaedic implants; Metal 3D printing materials; Application and development of bone defect repair material in orthopedic implantation; and the Research and development, application and processing of fully biodegradable Scaffolds (BDS) in coronary therapy. Medtec has also organized the Drug Delivery Device Conference in 2012, with the focus content of drug delivery materials and technology. This year’s conference—Technology Track B: Technology & Development of Combination Product—will retain related content and explore more technology information related to drug-device combination products. Xiaoming Feng, Director of Division of Standardization & Science Research, Institute for Medical Devices Control, National Institutes for Food and Drug control (NIFDC), will deliver an impressive speech entitled “Correlation techniques for drug-device combination product”.
Leading the industry with advanced manufacturing technology; free-of-charge events with rich content during the show period
The first launch of the “Advanced Manufacturing Forum” in 2016 was widely acclaimed. This year Medtec continues to join hands with ASQ to organise the “ Quality Control and Management in Manufacturing” , and explore how to use supplier-managed quality information systems, how to implement full life cycle quality management and control from the point of view of design, manufacturing and inspection, and the feasibility of BFR non-contact measurement by nickel-titanium alloy equipment for absolute flame temperature tests, among others, in order to offer strategies to RA/QA/QC engineers about how to respond to the rapid development and requirements of quality control systems.
In addition, Medtec China will also continue its previous popular conference “Medical Device Design” and create “Medical Device Packaging and Sterilization Technology,” “Processing Techniques of Medical Plastics and Product Innovation,” and “Electronic Medical” events to explore the medical device design concept, and manufacturing technology and development trends.
Medtec 2016 onsite scene
Medtec China will continue to organize free forums and events regarding overseas market analysis, new technology presentations and quality side events, including the Siemens lecture Hall that will talk about Digital Enterprise for Medical Devices from Siemens PLM Software, and the Purchasing and communication meeting from Shanghai MicroPort.
To obtain more information, please visit the Medtec China official website: www.medtecchina.com.
VisitConference Media Contact:
Carina Li
UBM China
T：+86 10 5765 2823
