We provide turn-key solutions for Western medical device & In-Vitro Diagnostic companies with CFDA regulatory and commercialization services in China. Our staff are bilingual and bicultural with practical industry experience. We have accelerated many Western medtech companies entry into China’s market.
MEET THE CHINA MED DEVICE TEAM
Grace Fu Palma
Grace Fu Palma founded CMD in 2011. She brings 20+ years of industry experience to the medical device industry. Grace has extensive management experience in marketing, business development, partnerships, and international commercialization from large multinational corporations (Hewlett Packard Medical Products Group, Phillips Healthcare) to start-ups (Teratech Corp). As the founder of the Chinese American Heart Association in 2005, she built the 500-member leading cardiovascular clinicians and scientists’ society with Chinese origins. The combination of cross-cultural mentality and deep Sino-U.S. medtech knowledge and professional experience in China and the United States has enabled CMD to help more than 50 medtech companies with their China entry and growth since its inception.
Grace Fu Palma is originally from Beijing, China and graduated with a Bachelor’s degree from Beijing University and an MBA from Yale University.
Tony Liu has more than ten years of CFDA regulatory experience from premarket approval to post-market surveillance and quality compliance. He was mentored by a top CFDA review chief. His career spans from R&D engineer to CFDA regulatory manager and supervisor at Beijing JR Technology Company, Philips Healthcare and Brady Regulatory Services Tech. His technical knowledge combined with his seasoned wide range of regulatory practical experience has enabled him to not only successfully obtained many CFDA approvals for the most complex class III medical devices but also to have established GMP approved facilities with clean rooms in China. Tony is leading a team of 20 regulatory professionals in Beijing focusing on CFDA medical device/IVD regulatory services in the following areas: Premarket: registration, clinical evaluation and trial, QMS establishment and audit, CFDA manufacturing license. Post-market: distribution license, adverse event and recall, labelling and manual, CFDA advertisement approval. GMP and regulatory compliance assessment and audit preparation.
Tony received BS from Northern Industrial University with joint degree in Physics and English.
Jason Zhang, MD
Director of CRO
Jason has 10+ years of experience in clinical research and clinical trial across a wide range of medical devices and IVDs. He has proven track record in working with CFDA to develop the optimum clinical trial plan, manage the on-going communication, effectively addresses the unexpected or challenging issues during the clinical study. His extensive experience covers the entire spectrum of clinical trials from site selection to the preparation of PRT, CIB, CRF, ICF, IRB, and PRT discussion meeting, clinical data monitoring, management, statistical analysis, clinical research, evaluation and reporting and final site closing. Product examples include, but not limited to: NanoFuse for bone trauma, Hemoconcentrator, Focused ultrasound for contouring, Precision infusion project, Polysaccharide hemostatic material project. MR-HIFU（MR guided High Intensity Focused Ultrasound）in Uterine Fibroid treatment, MRI imaging systems etc.
For IVD types of products, Jason has helped with blood gas analyzer, automatic blood type analysis system, erythrocyte sediment rate analyzer, different PCR-fluoroscopy based kits, enzyme-linked immunoassays, blood glucose / cholesterol dual detector etc.
He also worked as the clinical affairs manage at Philips Healthcare, clinical data manager at Merck & Co. on HPV Vaccine, Herpes Zoster Virus Vaccine, Drug for primary insomnia, Study of immunological drugs for Alzheimer’s Disease (AD) etc.
Jason received MD from North China Medical College (NCMC) and master in Pathology from Peking Union Medical College （PUMC）with specialty in Clinical Medicine, Clinical Pharmacology, Pharmacology, and Medical Statistics etc.
Yi Elaine Wang,
Director of China Funding
Yi Elaine Wang brings 15+ years of extensive scientific background as well as business experience from medium size to startup companies at Richard Franklin & Company, Cell Signaling Technology, and Incyte Pharmaceutica. She has solid knowledge of PE, financial and business modeling, and developing pipeline of M&A and licenses. Her scientific background has enabled her to develop quantitative and statistical methods for cell signaling technology and help with R&D, marketing, product development, patent office to develop automation solutions. In addition, she led the analysis and human genome sequencing to address a wide range of scientific questions and the establishment of SOP process and documentations. Has publications and presentations at national and international conference presentations.
Yi Elaine Wang is originally from Beijing, China and graduated with Ph.D. in Biophysics, MBA from Brandeis and BA, Chemical Biology from Rensselaer Polytechnic Institute.
Supporting and Analysts Team
All of our CMD Boston office staff received MBA degrees from the leading U.S. universities and BA/BS from universities in China. In addition to our U.S. based staff, our partnership offices in Beijing, Shanghai and Nanjing implement and support our China commercial, CFDA regulatory and funding activities.
In my twenty years of Class Ill medical device experience, I have not had the pleasure of working with a Chinese regulatory firm as talented and knowledgeable. As CFDA is increasing their technical and clinical review, it is one of the few companies staffed to assist medical device companies in this area. Their focus and dedicated support has exceeded our expectations. In my search for a strategic partner in China, they exceeded the other companies in all areas. While they have a very experienced Regulatory and Marketing team, their technical engineering, clinical, and international project management expertise place them above other companies in this area.
Vice-President, Global Regulatory/Clinical Affairs
China Med Device (CMD) has brought a great deal of knowledge and understanding to our team to help us navigate the complexities of bringing a product to market in China. Specifically we have gained a much better understanding of the ins and outs of the China medical device market and choices of business models. CMD has walked us through the very complicated process CFDA registration guiding us not only from regulatory documentation and testing perspectives but also how the process will impact the reimbursement downstream
Vice President of Finance
I had the opportunity to work with China Medical Device Group on a research project to inform our portfolio and regulatory strategy for entering the Chinese Marketplace. Grace's extensive experience in medical device has enabled her to independently and efficiently evaluate our product portfolio and assess our needs. They exceeded my expectations on quality and amount of data they were able to collect and we now have a strategy that has been informed by real data that will ultimately ensure our business success in the years to come.
Director of Marketing
Regenerative and Orthopedic Company, CA, USA
China Med Device (CMD) has brought a great deal of knowledge and understanding to our team to help us navigate the complexities of bringing a product to market in China. Specifically we have gained a much better understanding of the ins and outs of the China medical device market and choices of business models. CMD has walked us through the very complicated process CFDA registration guiding us not only from regulatory documentation and testing perspectives but also how the process will impact the reimbursement downstream ...
Vice President of Finance
On the fund raising front, what sets CMD apart is their understanding of the China market and key needs of Chinese investors. Their detail to preparation is second to none. Within a few months after our market access study, CMD was able to introduce us to solid investment sources.
We have been very impressed with CMD’s deep understanding of the medical device industry and investment landscape.