March 08, 2010
China Medical Device Trials - Current and Beyond
BEIJING, China, 26-27 FEBRUARY 2010 – China is the third largest medical device market in the world. In China, regulating medical device clinical trials is still in the beginning stages and changes are being made in order to improve the regulatory system. Therefore, medical device executives are striving to understand these emerging regulatory requirements. At the same time, challenges in completing studies within a specific time frame, clinical trial design and statistics analysis are also trouble areas for medical device executives.
Noppen’s 2nd China Medical Trial and Safety Surveillance, co-organized by the Shanghai Clinical Research Center (SCRC) and attended by over 60 industry professionals including SFDA government officials, international government officials, senior executives and Regulatory Affairs Directors, took place on the 26-27 February in Beijing, China. The event provided knowledge of changing government regulations, explored the clinical trial process and explained how to build a successful clinical trial strategy.
Influential government speakers included Sun Zhuohui, Former Director, Center for Medical Device Evaluation, SFDA who presented on the most up-to-date regulations for medical devices in China and Michael Kravchuk, Deputy Country Director, FDA China who spoke on the American prospects for medical device clinical trials and comparisons with China. Both speakers were very well received. Keynote speaker Prof. Cong Yulong, Chief Commissioner, Chinese Society of Laboratory Medicine, CMA presented solid information about the clinical expectation of IVD reagent and tips for IVD clinical trials. Prof. Cong was singled out as one of the top speakers at the conference and attending delegate’s even gave up their coffee break to extend a very informative Q&A session with him. Another speaker who stood out on the day was Prof. Li Wei, Reevaluation Expert, Medical Device Clinical Trials, SFDA who gave practical information as to how biostatistics are used in medical device clinical trials. As stated by Xia Huiqun from the SCRC, the conference was “inspiring and had a good combination of officials, professionals and experts”.
As most CROs have originally focused on pharmaceutical clinical trials, by directing interest towards medical device clinical trials they will further develop and expand this profitable market. Comprehensive panel discussions were held on the advantages and disadvantages of carrying out these medical device clinical trials in China. One of the panels was moderated by Ivan Zhai, Chief Operating Officer, R&G PharmaStudies Co Ltd who thinks that ”the conference is getting better and better.” As acknowledged by Michael Kravchuk, FDA China, “this was an excellent, informative event, I’ve learned a lot. All the topics were important and well presented. Please keep the conference going, I’d like to attend the conference next year”.
Chairperson of the event was Prof. Mi Xianqiang, Director and Associate Professor, Institute of Medical Device Assessment and Management, University of Shanghai Science and Technology, who spoke on medical device safety surveillance and evaluation systems. Prominent speakers included Prof. Xi Tingfei, Former Director of Medical Device Center, National Institute for the Control of Pharmaceutical & Biological Products, SFDA who presented on biomedical device development and bio-device clinical trials; Isabella Liu, Senior IP Associate, Dorsey & Whitney LLP who conveyed the legal considerations for medical device companies; and Prof. Gu Hanqing, Secretary General, Chinese Society for Biomedical Engineering who answered some frequently asked questions about medical device clinical trials.
Other topics discussed included the healthcare reform and its influence on the Hospital Purchase Scheme; the scientific attitude towards medical device clinical trials and an examination of medical device risk management. Noppen’s 2nd China Medical Trial and Safety Surveillance presented the most influential information gathering for the medical device industry making the event a great success, which can be illustrated by the positive comments from attending delegates. Charlotte Heung from Biosensors International Ltd. said “Impressive presentations & discussions from the government, experts & experienced professionals” and Donna Tang from PerkinElmer declared that it was a “very good event indeed”.
Noppen (Shanghai) Co., Ltd. is one of the leading producers of business conferences and professional trainings in China. Driven by the desire for excellence and supported by an unparalleled understanding of the China market, Noppen has delivered exceptional events since 1998. Our top-level business connections paired with our close relations to the many levels of Chinese Government have given Noppen an edge our competitors just can’t match.
Catriona Scanlon, Communications Manager
Noppen (Shanghai) Co., Ltd.
+8621 6085 1000 ext 226
(Source: Noppen Co., Ltd.)