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.
Director of Quality Assurance
Jason Liang is the Quality Assurance Director of China Med Device. He has 15+ years of QA/RA experience in medical device/IVD. He has held QA and RA management positions in several international corporations including Philips, Intertek, and TÜV Rheinland.
Jason is veteran auditor of medical device/IVD QMS for both international and domestic manufacturers in China. He is an expert on ISO 13485, QSR 820, China cGMP and understands the QMS dynamics between China, US, and EU. He has performed audits on a wide range of manufacturers in medical devices and IVDs (active, non-active), such as GE, Shimadzu, Fukuda, Panasonic, and many China domestic manufacturers.
Jason is a seasoned QMS trainer. His major training experience includes:
- ISO 13485 QMS training;
- European IVD Directive 98/79/EC, medical device Directive 93/42/EEC, and Directive 2007/47/EC training;
- Application of ISO 14971 risk management, including assessment of essential performance for IEC 60601-1 3rd edition;
- Application of IEC 62366 medical device usability; and
- China cGMP training.
12+ year experience in the regulatory management of the complete product life cycle of medical devices and IVD. Held leadership positions in RA/QA/QC. Led and executed numerous premarket submission of IVD and passive medical devices. Have extensive training and experience in GMP, QMS and helping companies pass CFDA GMP qualification inspection. Supervised and established 3 medical device manufacturing facilities from grounds up: obtained manufacturing facility CFDA certificates and the associated CFDA products registration.
Worked extensively with CFDA testing centers to support type testing and biocompatibility testing to meet CFDA GB/YY standards
He received BS in bioscience engineering degree from Beijing Union University
Responsible for the construction of the company’s factory buildings and supporting facilities and equipment (including clean workshops); the development and management of company QMS/GMP, products registration and post market compliance (multiple AEs); planning for product development and R&D direction, managed and passed the first physical examination of “Implementation Rules for Aseptic Medical Devices Production”. Established and managed the production workshop for environmental testing, process water quality testing, semi-finished product protein content detection, sterility testing, endotoxin detection, finished product loading detection, moisture content detection, sterility testing, endotoxin detection, isoelectric point Electrophoresis. Assist in routine electrophoresis, rabbit pyrogen test, HPLC and GC detection. Established the operational SOPs involved in the testing in accordance with the National Pharmacopoeia.
Training and Certifications: China Medical Device Industry Association Inspector Training Certificate (Qualified), Internal Auditor of Quality Management System, Aseptic Medical Device Production Management and Quality Control by the National Food and Drug Administration Training Center, Risk Manager Training, Training Institution, Medical Equipment Sterility Testing Staff Training Course by China Medical Device Industry Association.
Mr Rao has 10+ year CFDA registration, type testing and technical trouble shooting at the top six CFDA testing centers in China. He personally has been involved in 100+ CFDA registration and type testing. He has seasoned practical knowledge of electrical safety & EMC standards, X-ray imaging standards, radiotherapy standards as well as IVD standards. He is skilled at using various electrical test equipment indecently. In addition, his deep understanding and knowledge of IEC 60601 series standards, part of IEC 61223 series, and IEC 61010 series standards, as well as China GB & YY standards enables him to draft and perform test protocols across a wide range of devices from active to passive to IVD.
In the past, Mr Rao has worked as senior RA specialist at Hologic China. The types of projects that Mr Rao has been involved in but not limited to are: Full Field Digital Mammography systems, Digital Breast Tomosynthesis Mammography system, Mammography diagnostic workstation software, Mammography CAD software, RF generators, gamma cameras and detectors, Radiotherapy systems, Radiotherapy navigator, Cochlear implant systems as well as IVD systems.
Mr Rao received his BS in Physics in 2005 from Nankai University, Tianjin, China.
Business Development Director of China Med Device, LLC.
Richard has 5+ years of experience in engineering project management and new product launches with multiple manufacturers in the medical device industry in the U.S. and China. His responsibilities included product development, operations & quality improvement, CFDA registration, FDA audits and product recalls at Chinese manufacturing sites in China, as well as experience in FDA 510K and CE Mark. He introduced new products to both U.S. and China markets across a wide range of products and has extensive experience at process validation and verification (packaging, sterilization validation, and FDA DHF, design, supplier sourcing, qualification, quality management).
Richard has deep understanding for ISO 13485, QSR 820, and ISO 14971:2012 risk management. He led multiple quality improvements efforts in Kaizen and ECN projects. He also participated and facilitated product recall and multiple FDA audits in both US and China.
Richard has double degrees in Biomedical Engineering and Applied Mathematics and Statistics from Stony Brook University (State University of New York).
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.