On April 22, 2015, approval was granted for the registration of a medical device for decellularized corneal stroma from Shenzhen Ainier Corneal Engineering Co. The product was approved for registration by the State Food and Drug Administration in accordance with the Special Approval Procedures for Innovative Medical Devices (Trial). The product is made from porcine cornea, prepared by virus inactivation and decellularization, etc. It is the extracellular matrix of porcine cornea, which consists of the anterior elastic layer and part of the stromal layer, and the main component is collagen. It is clinically indicated for the treatment of not-yet-perforated corneal ulcers for which medication is ineffective, as well as for the temporary coverage of corneal perforations.
According to the "Special Approval Procedure for Innovative Medical Devices (Trial)", the applicant will submit the application for product registration to the Administrative Acceptance Center (AAC) after obtaining the "innovative" status, and the "Special Approval Procedure" will only be activated after the application is accepted. So how long did it take for the "special approval" of the above two innovative products? (The following table uses the "end of the publicity period of the innovative product" as the starting time of the program. (The calculations do not take into account the case where the application was made under the ordinary procedure before the innovation was applied for.)