The State Drug Administration ("SDA") has recently issued the Guiding Principles for the Examination of Registration of Medical Devices for Preventing and Treating Rare Diseases (the "Guiding Principles").
The Guiding Principles provide for the "applicable scope", "communication", "pre-clinical studies", "basic principles for the exemption from clinical trials", "basic principles for clinical trials", "criteria for a marketing approval", among others. The Guiding Principles stipulate that, before filing an application for the registration, an applicant may submit an application for communication to the relevant product technical review department, to confirm whether these Guiding Principles apply to its application and what clinical evaluation approaches should be adopted. Additionally, the Guiding Principles expressly state that, if the pre-clinical studies conducted for a particular type of medical devices used to prevent and treat a rare disease are insufficient to demonstrate that benefits brought to patients using this type of medical devices in clinical treatment significantly outweigh the risks resulting from this use, clinical trials should be conducted. Furthermore, the Guiding Principles clarify that during the technical evaluation of a type of medical devices helpful in preventing and treating a rare disease, conditions in four aspects, including "specifying a time limit for production evaluation after its marketing", may be set, in consideration of product risks and benefits and other factors, to conditionally approve its marketing.