China's rapidly changing regulatory environment will likely have a short-term negative impact on the overall market. A new regulatory system, established by the SDA in 2001, was designed to streamline a confusing regulatory framework. AQSIQ also introduced a new certification system in 2002 for certain medical equipment. It is a step towards resolving national treatment and transparency issues, though expensive, time-consuming, and redundant testing requirements remain. It is unclear if or when this regulatory and certification system will be revised.
