下载后可任意编辑体外诊断试剂注册管理办法 en12024 年 4 月 19 日下载后可任意编辑SFDA State Food and Drug AdministrationCircular on Printing and Issuing the Measures for the Administration of In-vitro Diagnosis Reagents (Interim)Authorized by MD Dept. SFDA [ ] No. 229The appropriate food and drug administrations (drug administrations) in provinces, autonomous regions and municipalities directly under the central government, The Measures for the Administration of In-vitro Diagnosis Reagents (Interim) was approved by the State Food and Drug Administration of the People’s Republic of China on April 3rd, and is hereby printed and issued, and shall be observed and implemented accordingly. State Food and Drug Administration April 19, Measures for the Administration of In-vitro Diagnosis Reagents (Interim)Chapter 1 General ProvisionsArticle 1 The Measures for the Administration of In-vitro Diagnosis Reagents (Interim) is formulated in accordance with the Regulations on the Supervision & Administration of Medical Devices and the Measures for the Administration of Medical Device Registration, with a view to regulating the administration of in-vitro diagnosis reagents. Article 2 The Measures applies to the R&D, clinical trials, registration inspection, product registration and supervision & administration of in-vitro diagnosis reagents. Article 3 The in-vitro diagnosis reagents mentioned in these Measures refer to the in-vitro diagnosis reagents administered as medical devices, including the reagents, reagent cartridges, calibrators, quality controls, etc. for in-vitro inspection of human body specimen (various body fluids, cells, tissue specimen, etc.) in the course of disease prevention, diagnosis, treatment monitoring, prognosis observation,...
