China: Special Review and Approval Process for Innovative Medical Devices Draft

The government aims to promote and support growth and innovation in China’s medical device industry. To this aim, the CFDA has released a draft of a new process to increase the efficiency of the review and approval process for innovative medical devices.


  • The applicant must be a locally incorporated entity in China. (This includes foreign owned enterprises and joint ventures.)
  • The applicant must own independent intellectual property rights to the medical device, meaning the applicant is the owner or the licensee of Chinese invention patents.
  • The applicant must have already completed early stage research.
  • The device must be made in China.
  • The device must be the first of its kind and demonstrate improved safety or efficacy over existing products.
  • The device must have significant clinical application value.

To apply through the special process, applicants should submit a file to the provincial FDA. The provincial FDA will then relay the application with their preliminary opinions to the SFDA for final approval.