Related Laws and Regulations about IVD Approval in China

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