China's medical devices market is the largest in Asia outside of Japan, and also one of the fastest growing in the world. Imports account for approximately 50% of China's $2.5 - 3.0 billion medical device market, with the U.S. controlling around 36% of the total imported products. As China's WTO commitments are gradually phased in, the instability of the regulatory environment will negatively affect profit expectations. Over the next 10 to 12 years, however, China should deliver the type of returns it is very much capable of.
should not list clinical trial sites. After companies obtain the approval letter and contract with clinical trial sites, companies should file for the record with SDA the names of the sites. When sites are increased or closed, companies should file an explanation for the record with SDA. 4. Appropriate sample sizes should be determined on a case-by-case basis. The current limitations on sample size do not take into account specifics regarding the disease and drug. 5. SDA should issue an explanatory note and further communicate with customs to solve the problem regarding export of blood samples. 6. SDA should consider only requiring inspection of the initial batch of samples used during clinical trials. 7. Authorities need to promulgate more detailed rules and procedures. SDA is beginning to revise and expand regulations on drug safety surveillance. WHO, ICH guidelines should be referenced so as to gradually improve Chinese regulations in making them more consistent with international regulations, which may also lead to beneficial information exchange.
