Grace Palma, CEO of China Med Device
On my flight to China, my seat mate is a Harvard Medical School professor specializing in stem cell research. We were talking about differences of research in the US and China. We mutually agreed to the following:
These comments may be a little stereotypical but there is truth based on my 20+ years of medical device commercial experience between the U.S. and China. With the global education and research exchanges, China will be ahead in 10 years or so to bring these research results to commercial success. It could be shorter but other factors such as regulatory approval, preclinical and clinical. This is my gut guess.
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ companies’ success.