| 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 |
Below are the related regulations for IVD approval in China
1. The Regulations for the Supervision and Administration of Medical Devices (Decree No.650 2014)-main regulation
2. Administrative Measures for the Registration of In Vitro Diagnostic Reagents(CFDA Order No. 5 2014)
3. The Guidelines for the Instructions of In Vitro Diagnostic Reagent Preparation (CFDA Notice No. 44 2014)
4. The Guidelines for the Clinical Trial of In Vitro Diagnostic Reagent
5. The Guidelines for the Compiling of Package Insert of In Vitro Diagnostic Reagen