The US-China Joint Commission on Commerce and Trade (JCCT) Pharmaceutical and
Medical Devices Subgroup meeting took place on April 13 in Chengdu,
China. The Director General of the Department of Medical Devices
in the SFDA, Wang Baoting,
presented on the SFDA’s efforts to finalize “The Supervision and
Administration Measure of Medical Devices.” This Measure outlines
the responsibilities of various medical device regulation agencies
and is slated to be published later this year.
Wang stated that a Center of the Medical Device Standards Administration will be established. This Center will research standards systems, focus on device classification, and supervise standardization committees.
The Director General also reported that the SFDA has had an increase in capacity and in staffing given the increase in regulations and in medical device imports.
At the meeting, the Medical Device Task Force discussed requirements
on clinical trials, country of origin registration, combination
products, and classification of diagnostic imaging equipment and
IVDs. For each of these agenda points, the Director General Wang
answered questions from US medical device industry experts about
the complexities and problems that arise from existing regulations
The Director General stated that these concerns would be taken
into consideration as medical device rules and regulations are