On February 6, 2018, China’s Food and Drug Administration (CFDA) and the Center for Medical Device Evaluation (CMDE) issued a new draft guidance for the approval of medical devices intended to treat rare diseases. The guidelines set out requirements for applicants to provide detailed past research data on the relevant rare diseases. Applicants are also required to fully explain how the product works, provide a comparison with a similar product on the market, clearly declare any safety risks, and conduct a full pre-clinical assessment of any risks.
The guidelines allow a conditional approval pathway for medical devices that meet urgent clinical needs. They also state that applicants could choose a clinical evaluation, instead of conducting a new clinical trial, if there is already a similar medical device in the same category on the market. The guidance confirms that overseas trial data can be used to support medical device applications for rare diseases, in line with recent CFDA reforms.