Registration fee for second-class medical devices

In order to implement the spirit of the State Council's Opinions on Reforming the Examination and Approval System for Medicines and Medical Devices (Guo Fa [20 1 5] No.44), according to the Notice of Shanghai Finance Bureau and Price Bureau on the Administration of Registration Fees for Medicines and Medical Devices in this Municipality (Shanghai [20 16] 13), Shanghai on the 20th.

1 .201March 61Applicants who submit an application for registration of drugs and medical devices to the US Food and Drug Administration in Shanghai shall pay the registration fee according to the registration fee standard of drugs and medical devices in Shanghai.

Second, in order to further clarify matters related to the registration fees of drugs and medical devices and facilitate applicants to handle them, the US Food and Drug Administration in Shanghai has formulated the Guidelines for Supplementary Drug Application and Re-registration Fees in Shanghai, the Guidelines for the Registration Fees of Class II Medical Devices in Shanghai and the Instructions for Paying Administrative Fees for Drugs and Medical Devices in Shanghai.

3. According to the Notice of the National Development and Reform Commission and the Ministry of Finance on Printing and Distributing the Administrative Measures for Registration Fees of Medicines and Medical Devices (Development and Reform Price [20 15] 1006), the registration fees of medicines and medical devices are evaluated once every five years in principle, and the US Food and Drug Administration in Shanghai will make appropriate adjustments according to the evaluation.

Four, the registration applicant in the process of paying the registration fee for drugs and medical devices products, you can feedback to the business acceptance center of the US Food and Drug Administration in Shanghai.