Which medical devices must pass 3C product certification

Theoretically speaking, medical devices are mandatory to do 3C

But in practice, many do not do

The following products have special rules for the implementation of mandatory certification, it is estimated that it is difficult to escape:

"Medical Device Class Compulsory Certification Implementation Rules" (ECG machine) CNCA-08C-032: 2001

"The Implementation Rules for Compulsory Certification of Medical Devices (Hemodialysis Devices) CNCA-08C-033:2001

Implementation Rules for Compulsory Certification of Medical Devices (Extracorporeal Circulation Tubes for Blood Purification Devices) CNCA-08C-034:2001

Implementation Rules for Compulsory Certification of Medical Devices (Hollow Fiber (Dialyzer) CNCA-08C-035:2001

"Rules for the Implementation of Compulsory Certification of Medical Devices" (Implantable Cardiac Pacemaker) CNCA-08C-036:2001

"Rules for the Implementation of Compulsory Certification of Medical Devices" (Medical X-ray Diagnostic Equipment) CNCA-08C-037:2001

"Rules for the Implementation of Compulsory Certification of Medical Devices" (Medical X-ray Diagnostic Equipment) CNCA-08C-037:2001

Medical Devices: Compulsory Certification of Medical Devices

Implementation Rules for Compulsory Certification of Medical Devices (Rolling Blood Pumps) CNCA-08C-038:2001

Implementation Rules for Compulsory Certification of Medical Devices (Rolling Pulsatile Blood Pumps) CNCA-08C-039:2001

Implementation Rules for Compulsory Certification of Medical Devices (Bubble Oxygenators) CNCA-08C-040:2001

"Rules for the Implementation of Compulsory Certification of Medical Devices" (Heat Exchangers) CNCA-08C-041:2001

"Rules for the Implementation of Compulsory Certification of Medical Devices" (Heat Exchange Tanks) CNCA-08C-042:2001

"Implementation Rules for Compulsory Certification of Medical Devices" (Silicone Rubber Pumps)

"Rules for Compulsory Certification of Medical Devices" (Silicone Rubber Pumps) Implementation Rules for Compulsory Certification of Medical Device Products (Silicone Rubber Pump Tubing) CNCA-08C-043:2001