In February 2014, the China Food and Drug Administration released Trial Procedures for the Special Examination of Innovative Medical Devices (Special Procedures). CFDA released a draft of the Special Procedures for public comment in mid-2013, described here. Under these special procedures, if a medical device meets certain criteria it will be eligible for “priority” evaluation and approval procedures. Applicants for these procedures may be domestic or foreign companies. The Special Procedures went into effect on March 1, 2014.
The Special Procedures lay out eligibility criteria in three areas. First, the applicant must hold an invention patent on the core technology in China; the patent or use rights in China were legally transferred to the applicant; or the State Intellectual Property Office of the State Council has already published the patent claims on the core technology. Second, the primary work on the product’s design and use mechanisms must have been the first of its kind in China; its safety or functionality must be a fundamental improvement over comparable technology; it must be leading technology internationally; and the device must have clear clinical value. Third, and finally, the applicant must have completed the preliminary research and finalized the design of the product; the research process must be accurate and controlled; and the research data must be complete and traceable.
If the device meets those criteria, the applicant must submit standard business documentation, IP-related documentation, a summary of the research and development process and results, and technology documentation to the relevant regulators. The Special Procedures set forth more detailed requirements on the type of technology documentation that must be provided.
Several levels of approval are required before a device may be eligible. Domestic applicants must submit an application to the food and drug regulatory authority in the province where they are located. Once that local regulator makes an initial decision to accept the application after 20 days, the application is passed on to CFDA. A foreign applicant applies directly to CFDA. Once CFDA has initially accepted either a domestic or foreign application, it is passed on to a special office that will be established for innovative devices inside the Center for Medical Device Evaluation (CDE), which will organize a panel of experts to evaluate the device. The panel will issue a decision within 40 days of accepting the application. However, before a final decision is issued, the applicant’s name and the name of the product will be published on CDE’s website. After a period of 10 days, during which objections may be filed, a final decision will be made.
“Innovative devices” will receive priority consideration in various respects, i.e., acceptance for evaluation, communications with CFDA, evaluation of clinical studies, and ultimately final approval by CFDA. The Special Procedures do not set forth a specific time frame according to which CFDA must ultimately approve the device for marketing. They only state that the device will be given priority.
Medical device companies doing business in China should monitor the implementation of the Special Procedures to determine whether it may provide an advantage to their products there.