The global application of molecular diagnostics has gradually evolved from the initial diagnosis of infectious diseases to the current personalized treatment and genetic disease screening, which has highly promoted precision medicine.
The essence of precision medicine is the analysis and identification, verification, and the application of biomarkers for large sample populations and specific disease types, so as to accurately find the cause of the disease and classify the different states and processes of a disease that eventually treat the disease.
Molecular diagnosis has entered a period of maturity in the areas such as infectious diseases and sexually transmitted diseases that involve the detection of pathogens, but in other new areas such as personalized treatment of cancers, genetic disease screening, the diagnosis is still under development, therefore, the huge growth potential in those new areas is still expected.
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+ western companies’ entry.