Drugdu.com expert's response:

Medical devices are classified and managed into three categories ‌in ascending order of risk level‌, with the Rules for the Classification of Medical Devices as the core basis.

1. Management Classification of Three Categories of Medical Devices

‌Class I‌: Medical devices with low risk, whose safety and effectiveness can be ensured through routine management, such as ordinary medical surgical masks and medical examination gloves.

‌Class II‌: Medical devices with moderate risk that require strict control and management to ensure safety and effectiveness, such as clinical thermometers and non-invasive monitors.

‌Class III‌: Medical devices with relatively high risk that need particularly strict control measures to ensure safety and effectiveness, such as implantable cardiac pacemakers and artificial joints.

2. Supporting Classification Management Rules

In addition to the risk classification of the products themselves, China also implements classified and hierarchical supervision for the production and operation links, clarifying the responsibilities of regulatory authorities at different levels, improving the scientific level of supervision, and ensuring the safety and compliance of medical devices throughout the whole process.