Special Review Procedure for Innovative Medical Devices
Article 1 This Procedure is formulated in accordance with the Regulations for the Supervision and Administration of Medical Devices, the Provisions for Medical Device Registration and the Provisions for In-Vitro Diagnostic Reagent Registration in order to ensure the safety and effectiveness of medical devices, to encourage the research and innovation of medical devices, to accelerate the promotion and application of new technologies for medical devices and to promote the development of the medical device industry.
Article 2 The medical device review in any of the following circumstances is applicable to this Procedure:
(i) If the applicant owns the invention patent of the core technology of the product in China through its leading technological innovation activities, or obtains his patent right or right of use in China by means of transfer in accordance with law, the application time for the special review of innovative medical devices shall be no more than five years from the date of patent authorization; Or, the application for the invention patent of core technology has been publicized by the patent administration department under the State Council, and a search report stating that the core technology protocol of the product is novel and creative is issued by the Patent Search and Consultation Center of SIPO.
(ii) The applicant has completed the preliminary research of the product with the result of a nearly finalized product. The research process is authentic and controlled, and the research data is complete and traceable.
(iii) The main working principle or mechanism of action of the product is the first of its kind appeared in China. The product performance or safety is fundamentally improved compared with equivalent products and technologically, the product is at an international leading level and has a significant value in clinical application.