Release date: 2017-10-30
Recently, the CFDA issued the "Reply to the No. 2254 of the Fifth Session of the 12th National People's Congress (Recommendation on Reforming the Registration and Approval System and Supporting the Research and Development of Domestic Innovative Medical Device Enterprises)" (hereinafter referred to as the proposal), it is worth noting that In this proposal, it was clearly stated that the National Development and Reform Commission endorsed the proposal of nine representatives of Ou Chengzhong to reduce the application fee for innovative three types of medical device products.
At present, the registration fees for the three types of medical devices are as follows (unit: 10,000 yuan)
Note: The registration fee for the first registration of innovative medical device products proposed by small and micro enterprises is exempt from registration fees.
In April 2015, in order to strengthen the management of medical device registration fees, regulate registration fees, protect the legitimate rights and interests of registered applicants, and promote the healthy development of registration, according to the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices, the Ministry of Finance and the National Development and Reform Commission Issued the Notice on Re-issuing the Administrative Charges for the Food and Drug Administration of the Central Administration (Cai Shui [2015] No. 2), and established the registration fee for medical device products, including the initial registration fee, change of registration fee, and continuation. Five specific items, such as registration fee, clinical trial application fee, and medical device product registration expedited fee.
In May 2015, the National Development and Reform Commission and the Ministry of Finance issued the “Administrative Measures on the Registration Fees for Pharmaceuticals and Medical Device Products†(Development and Reform Price [2015] No. 1006), which is stipulated by the Food and Drug Administration in accordance with the “Registration Fees for Medical Device Products= The daily fee standard × the number of people required for registration × the number of days required for registration†formulates specific charging standards. Among them, the daily fee standard is calculated at no more than 2,400 yuan per person per day. The specific daily fee standard and the number of people and the number of days required for registration shall be determined by the Food and Drug Administration in accordance with relevant management regulations and actual needs.
In May 2015, the CFDA issued the “Notice on the Issuance of Registration Fees for Pharmaceuticals and Medical Device Products†(No. 53 of 2015), which clarified the application for the initial registration of innovative medical device products proposed by small and micro enterprises, exempting their registration fees. (Tips: Innovative medical device products refer to the Innovative Medical Device Examination Office of the State Food and Drug Administration, based on the “Special Approval Procedure for Innovative Medical Devices (Trial)†of the General Administration of the State Council. After the public announcement on the website, the product that agrees to enter the special approval process is approved.)
CFDA said that at present, the Party Central Committee and the State Council attach great importance to alleviating the burden of enterprises, and stressing that cleaning up and regulating the charges of enterprises is an important measure to optimize the development environment of the real economy and promote structural reforms on the supply side. In the "two sessions" in 2017, Premier Li Keqiang put forward the requirements for further tax reduction and fee reduction in the "Government Work Report".
In March 2017, the Ministry of Finance and the National Development and Reform Commission issued the "Notice on Clearing and Regulating Policies for a Group of Administrative Fees" (Cai Shui [2017] No. 20), canceling or suspending 41 administrative fees set up by the central government. , reduce the trademark registration fee by 50%.
In the next step, we will further strengthen the management of administrative fees, clean up the standard charging items, reduce the high charging standards, and improve the charging management system.
Source: Medical Valley
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