How the Recent U.S.-China Joint Commission Affects Medical Devices and Pharmaceuticals

In November 2015, key representatives of the U.S. and Chinese governments met to address bilateral trade issues. Officials discussed a number of important issues that affect the registration of medical products in China. According to the U.S. factsheet on the joint commission, U.S. and Chinese officials agreed that:

  • China will publish an annual report on drugs and medical device evaluations that includes performance efforts.
  • In 2016, China will draft a second round of medical device clinical trial exemption categories to expand the range of exemptions.
  • China is improving the registration process to facilitate communication between applicants and Chinese officials. For innovative medical devices, dedicated specialists will be involved in the registration process and communicate with the applicant upon request. For other medical devices, relevant departments of the China Food and Drug Administration (CFDA) will hold weekly consultations with applicants.
  • China will provide no less than a 30 day comment period when implementing new rules and regulations. China will also abide by technical barriers to trade laws.
  • China will treat imported medical devices the same as those that are manufactured or developed locally.

While these developments seem positive, the question is how quickly they will be implemented and enforced.