Tags: | NMPA | Medical Device | IVD | 药监局 | 医疗器械 | 诊断试剂 |

There are the following related Laws and regulations for IVD approval in China:

1. Provisions for the Registration of Medical Devices In Vitro Diagnostic Reagents (IVD)

2. Management Method of In Vitro Diagnostic Reagents Registration (Interim)

3. Principles and Procedures for the Coverage of Products Included in the Quality  Management System Examination for In-Vitro Diagnostic Reagent

4. Guidance for Manual of In-Vitro Diagnostic Reagent