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.