《Regulationsof the supervision and manufactureof medical devices》（CFDA NO 7 ORDER）http: www sda gov cn WS01 CL0053 103759 html《Regulationsof IVD registration》（CFDA NO 5 ORDER）
Chapter 1 General ProvisionsArticle 2 Where any IVD reagent is sold or used within the territory of the People’s Republic of China, it shall apply for the registration
The Regulation hereby formulated with a view to ensuring safety and effectiveness of medical devices, protecting human health and life safety Article 2The food and drug re
2 Administrative Measures for the Registration of In Vitro Diagnostic Reagents(CFDA Order No 5 2014)4 The Guidelines for the Clinical Trial of In Vitro Diagnostic Reagent
(Ⅰ) Class Ⅰ2 Products for sample processing, e g hemolytic agent, diluents, staining solution, etc Except defined specially as Class Ⅰ and Ⅲ, the products belong to
Issue date: May 27, 2015Notice is hereby given 1 Charging Standard for Registration Fees of Drugs and Medical Device Products(3) Detailed Implementation Rules for Medical
