Attachment 3

Enforcement Regulations for Charging on Registration of Medical Instrument Products
(On Trial)

According to Regulations on Registration of Medical Devices (Decree of China Food and Drug Administration No. 4), Regulations on Registration of in Vitro Diagnostic Reagents (Decree of China Food and Drug Administration No. 5), Notification about Re-announcement on Revenue from Administrative Charges of Food and Drug Administration Administrated by the Central Government and Notification about Publishing ‘Regulations on Charging Standard for Registration of Drugs and Medical Instrument Products’ and other relevant regulations, the enforcement regulations are formulated. 
I. Payment Procedure of Registration Charges of Medical Instrument Products
(1) Initial application for registration 
The registrant puts forward initial application for registration of domestic medical devices of category III, imported medical devices of category II and category III to China Food and Drug Administration; China Food and Drug Administration shall issue the Notification on Payment for Administrative Licensing Items after acceptance and the registrant shall pay it as required. 
(2) Application for changing registration 
The registrant puts forward application for changing registration of licensed items of domestic medical devices of category III, imported medical devices of category II and category III to China Food and Drug Administration; China Food and Drug Administration shall issue the Notification on Payment for Administrative Licensing Items after acceptance and the registrant shall pay it as required. 
Regulations on Registration of Medical Devices and Regulations on Registration of in Vitro Diagnostic Reagents stipulate that the application fees for changing registration are not charged on amendment of registration items. 
(3) Extension of application for registration
The registrant puts forward application for extending registration of domestic medical devices of category III, imported medical devices of category II and category III to China Food and Drug Administration; China Food and Drug Administration shall issue the Notification on Payment for Administrative Licensing Items after acceptance and the registrant shall pay it as required. 
(4) Application for clinical test 
The registrant of medical devices puts forward application for clinical test to China Food and Drug Administration; China Food and Drug Administration shall issue the Notification on Payment for Administrative Licensing Items after acceptance and the registrant shall pay it as required. 
Catalogue of Medical Devices of Category III required to be examined and approved for clinical test is formulated, adjusted and published by China Food and Drug Administration. 
II. Explanation on Payment of Registration Fees of Medical Instrument Products 
(1) The registrant shall put forward application for registration of products in accordance with registration units and pay fees according to relevant stipulations; as for where required to be split according to relevant requirements, the split registration units shall be declared separately. 
(2) As for the initial application for registration as imported medical device of category II by the registrant, but it is confirmed as the medical device of category III after technical evaluation, the registrant shall exit registration procedure. The registrant shall re-apply for registration according to the administration category after confirming and pay additional price difference. 
(3) The registration charging standard according to Regulations on Registration of in Vitro Diagnostic Reagents is applicable to this enforcement regulation. 
(4) The registrant shall pay registration fee as required within 5 working days after receiving the Notification on Payment for Administrative Licensing Items; if the registration fee has not been paid as required, the registration procedure will suspend automatically. 
(5) After accepting the application for registration, if the applicant offers to withdraw application for registration, or China Food and Drug Administration has made a decision of disapproving licensing, the registration fees have been paid will not be returned. The registration fees shall be re-paid if the registrant puts forward application for registration again. 
(6) As for the initial application for registration as medical device of category III by the applicant, but it is confirmed as the medical device of category I or II after technical evaluation, the additional price difference of imported product shall be returned, and all paid fees of domestic product shall be returned. 
III. Preferential Policy towards Small and Micro Enterprise
(1) Preferential scope 
   The registration fee is waived as for the initial application for registration of innovative medical device proposed by small and micro enterprises. The innovative medical instrument products are those which are allowed to enter the special examination and approval procedure after being examined by related experts organized and being published at the website of the government by Examination Office of Innovative Medical Devices of China Food and Drug Administration on accepted special application for examination and approval of innovative medical devices based on the Procedure of Special Examination and Approval for Innovative Medical Devices (on trial) (SYJXG [2014] No. 13) issued by China Food and Drug Administration. 
(2) Materials required to be submitted 
   The registrant who meets conditions of Stipulations on Scale Division of Middle and Small-sized Enterprise (GXBLQY [2011] No. 300) shall submit the following materials to the Center for Acceptance and Reporting when applying for charging preferential policy towards small and micro enterprises. 
1. Application Form of Charging Preference towards Small and Micro Enterprises (see annexed table in Annex 2); 
2. Copy of Business License of enterprise; 
3. Tax Return of Corporate Income Tax of last year (must be sealed to confirm by tax department) or effective Statistical Table of last year (issued by statistics department); 
4. Examination Notification on Special Application for Approval of Innovative Medical Device issued by Center for Medical Device Technical Evaluation of China Food and Drug Administration. 
IV. Explanation of Other Matters 
(1) Fee payable matter: the registrant, who exits registration procedure as for registration of imported medical device of category III as category II, shall hold relevant approved document and pay additional price difference at Center for Acceptance Service and Reporting about Administrative Items of China Food and Drug Administration (hereinafter shorted for Center for Acceptance and Reporting) when declaring once more. 
(2) Premium return matter: if the incorrect remittance is made by the registrant, the registrant shall propose it and submit Application for Premium Return, Receipt of Remittance and General Pay-in Warrant of Nontax Revenue and other relevant materials; if the incorrect remittance is not made by the registrant, Division for Registration and Management of Medical Device of China Food and Drug Administration shall issue Notification on Premium Return to Center for Acceptance and Reporting; then Center for Acceptance and Reporting shall contact with the registrant and handle procedures of premium return according to relevant stipulations by the end of April or October each year after submitting materials like Application for Premium Return, Receipt of Remittance and General Pay-in Warrant of Nontax Revenue by the registrant. 
(3) Combination products: the registration fee of combination products shall be charged corresponding to that of substance which plays a major role.