Medical devices refer to instruments, equipment, apparatus, in‑vitro diagnostic reagents and calibrators, materials and other related articles intended for direct or indirect use on the human body. They are mainly used for the diagnosis, prevention, monitoring, treatment or alleviation of diseases, as well as the diagnosis, monitoring, treatment, alleviation of injuries or compensation for functions, running through the whole medical‑care process.
I. Core Classification (China‑based, by Risk Level)
Class Ⅰ: Low‑risk products whose safety and effectiveness can be guaranteed through routine control, such as medical masks, tongue depressors, medical cotton swabs, etc.
Class Ⅱ: Moderate‑risk products requiring strict control and management, such as clinical thermometers, sphygmomanometers, ultrasound diagnostic equipment, electrocardiographs, etc.
Class Ⅲ: High‑risk products requiring special measures for stringent control, such as artificial heart valves, implantable pacemakers, vascular stents, extracorporeal circulation equipment, etc.
II. Main Application Fields
Diagnostic Products: Used for disease screening and confirmation, such as CT scanners, Magnetic Resonance Imaging (MRI) equipment, blood‑routine analyzers, nucleic‑acid detection reagents, etc.
Therapeutic Products: Used for disease treatment or injury repair, such as ventilators, infusion pumps, surgical robots, laser therapy equipment, etc.
Monitoring Products: Used for vital‑sign monitoring, such as electrocardiogram monitors, pulse oximeters, fetal monitors, etc.
Auxiliary Products: Used for patient rehabilitation or daily‑life support, such as wheelchairs, hearing aids, intraocular lenses, prostheses, etc.
III. Core Requirements
Medical devices shall meet the standards of safety, effectiveness and controllable quality. Before market launch, they shall pass corresponding registration or filing review. Their production shall comply with GMP (Good Manufacturing Practices). Adverse‑event monitoring and re‑evaluation shall be carried out regularly to ensure clinical safety.
