Going to the RAPS 2018 Annual Conference October 1 – 4th in Vancouver? Visit our booth to get the latest updates on NMPA (formerly CFDA) and a Glamour Shot! China Med Device (CMD) is presenting and exhibiting at the upcoming RAPS Annual Conferencer. We are also the sponsor of Glamour Shot.
CMD’s CEO Grace Palma and Clinical Director Jason Zhang, MD, will present in“What are the Practical CFDA Compliant Clinical Trial Tips in China in 2018?” So join them in this event from 10:30-11:30 AM on Thursday, Oct 4th in Room 205-207 at the Vancouver Convention Center.
Please visit us at booth #502 to find out the latest updates and the major structural changes of NMPA (Formerly CFDA). To schedule a time with Grace or Jason to get more information about NMPA and to get advice on how to enter the Chinese market for your device or IVD product, simply email us at info@ChinaMedDevice.com.
We the thought leaders and execution experts. Let us guide you through these changes, from RA, clinical evaluation, CRO, to QA and post-market compliance. China Med Device is a CFDA certified legal agent.
Grace Fu Palma, a Sino-US MedTech veteran, founded China Med Device (www.ChinaMedDevice.com) to provide turn-key solutions for western medical device/IVD/combination products’ companies to enter China with regulation and commercialization services. Grace has 20+ years of experience driving global product strategy, commercialization, partnerships, and China operations for both large multinationals and startup companies. She has held a variety of management positions in marketing and operations at multinationals and start-ups. Grace founded the Chinese American Heart Association in 2005. She is a speaker at national regulatory meetings as well as a column contributor for US regulatory news and journals.
Jason Zhang, MD, has 10+ year clinical trial and management experience in China. With his expertise in clinical design, data quality in CRC and CRA, reporting and evaluation, Jason has managed the clinical trial for oncology positioning system, ultrasound, MRI and CT and other diagnostic products. He designed and completed the clinical trial for the 1st domestic Linear Accelerator in China with 75 patients in less than a year. It was approved by CFDA through Innovation Device pathway. He is also a patent owner at Philips and has several publications on MRI guided HIFU.
China has 5 times the U.S. population with extremely concentrated care. For instance, China’s 1st Affiliated Hospital of Zhengzhou University has annual visits of 100 million, whereas Mass General Hospital in Boston has around 1.5 million. The advantage of being able to recruit patients quickly and utilizing the NMPA (CFDA) compliant data to shorten regulatory approval time in China could help generate revenues years ahead from the 2nd largest medical device market, China.
Chinese culture and clinical practice are very different from that in the U.S. The accepted practice and international regulations of FDA are not always being applied the same way at NMPA (CFDA). Therefore, the value of the session is to equip you with key areas so as you can have the right strategy and tactics to shorten clinical trials and approval times.
You will be able to understand the China perspective. Receive actual tips on how to best work with your Contract Research Organization (CRO). Find practical ways to get to China before your FDA or CE approval. We will discuss how to be more proactive to improve the overall CRO process. You’ll also learn how to get your new products available faster for the Chinese population. We will cover these topics in our presentation:
China Med Device, LLC (www.ChinaMedDevice.com) provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, RA, clinical evaluation, CRO, QA and post market compliance. We are experts in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Combined, our management team also has 100+ years of experience in medical device and IVD. We have been successfully involved with 1,000+ CFDA certificates and 250+ companies’ success.