Medical Device Administrative Control System

Is Your Product a Medical Device?

What are the Factors Affecting the Risk Classes of General Medical Devices?

What are the Factors Affecting the Risk Classes of In Vitro Diagnostic Medical Devices?

How to complete an application for listing of Class II/III/IV General Medical Device? (Chinese Version Only)

How to complete an application for listing of Class B/C/D In-Vitro Diagnostic Medical Device? (Chinese Version Only)

The Roles and Responsibilities of Local Responsible Person

Application for Listing Rapid Antigen Tests for COVID-19 under Medical Device Administrative Control System