2019 Sep24-27,the 10th CIMDR Forum was held successfully in Suzhou!
It is so nice to celebrate the 10thanniversary for the China International Medical Device Regulatory Forum (CIMDR), which was founded by China Center for Food and Drug International Exchange (CCFDIE) since 2010.The Forum participants scale increased from hundreds at the beginning to thousands these years, and now it is the unique forum in China. For the last decade, the mission of CIMDRremainsthe same, which is to promote China’s policies and regulations on medical device, enhance international exchange and cooperation among foreign medical device regulatory authorities and evaluation bodies, regulate enterprises operation order, boost communication not only between enterprises and the government but also within the healthcare industry and push ahead the application of new technical standards and technological achievements, so as to improve the safety and effectiveness of medical device.
CIMDR has led to the popularization and advancement of China’s medical device policies and regulations, witnessed achievements attained in the promotion of up-to-date international concepts and strengthened and pushed forward relevant international cooperation and exchanges. Given that new medical devices and cutting-edge technologies have been constantly introduced into Chinese market, China's reviewers and regulatory officials need to unceasingly enlarge the highly specialized knowledge of scientific review, supervision and technological frontiers. CIMDR is committed to building a platform to expedite the adoption of China’s medical device regulatory policies and enhancing the exchange and collaboration among international medical device regulatory authorities and evaluation bodies, in the cause of greater development and progress in China’s medical device regulation.
There are 17 division topics in this Forum, such as the Medical Device Innovation Technology and Product, Medical Device Clinical Evaluation, UDI Implementation, Artificial Intelligence, In Vitro Diagnostics (Companion Diagnostics), etc.
As the invited guest for the Medical Device Clinical Evaluation Division, RAMED (法荟)president Ellen Jiang left for Suzhou immediately after her attendance at the MedTech Conference in Boston, and hosted the presentations on Sep 27 morning.
In these presentations, the most attractive one was the “FDA clinical trial design and review highlight”, which was presented by the RAMED/CR MedIcon CMO - Prof. Sun. Prof. Sun was awarded the first- and second-class prize conferred by the Committee of the National Advanced Science and Technology of China. When he landed the US, Prof. Sun had been worked as the FDA Leading Reviewer in CDRH/Senior Epidemiologist，Project Director/Mathematical Statistician in NIH/NCI，Professor of Duke Prostate Center Database and Biorepository Director in Division of Urological Surgery，Associate Professor/DoD Longitudinal Prostate Cancer Database and Director in Department of Surgery, Uniformed Services University of the Health Sciences，Senior Scientist of Wound Repair Enhancement Program in Naval Medical Research Institute，etc. Prof. Sun provided such an excellent presentation, which displayed the fundamental ideology of FDA, the rationality of clinical trial design, the evaluation of the statistical performance and the principles for the application writing. These highlights were not easy to hear and learn, and hope the highlights could greatly help the participants to work better in their R&D and clinical trial work.
In this Forum, RAMED (法荟) was active to communicate with our clients and colleagues. Guess everybody would be happy to drink the “RAMED water” during their heated discussion.
With the more intense competition in the clinical industry, the compliance for the manufacturer would play the essential role in the near future. How to help the entities to perform in compliance, and how to use the regulation to perform their competitive advantage. This is RAMED (法荟) expertise and RAMED (法荟) is ready to work with you for strengthen your essential competence.