The General Office of the State Drug Administration ("SDA") has recently issued the Procedures for the Special Examination and Approval of Innovative Medical Devices (Revised Draft for Comment) (the "Draft for Comment") for public consultation by June 15, 2018.
The Draft for Comment stipulates that, drug regulators may examine and approve Class II and Class III medical devices under these special procedures, provided that the medical devices satisfy three requirements, one of which reads as "the applicant has completed the preliminary studies for the product and created the fundamental prototype, and its studies are truthful and controllable and generate complete and traceable statistics". According to the Draft for Comment, a domestic applicant shall file an application to the provincial drug regulator at its locality for the special examination and approval of its innovative medical devices, while an overseas applicant is required to submit its application to the SDA for this purpose. Furthermore, the Draft for Comment notes that the office for examining innovative medical devices will determine the administrative classification of medical devices at the same time when it exams an application filed for the special examination and approval of innovative medical devices.
(Source: http://cnda.cfda.gov.cn/WS04/CL2051/227922.html)
