Drugdu.com expert's response:

I. Specific Definitions of Class I, II, and III Medical Devices

Class I Medical Devices

Definition: Medical devices with a low degree of risk, whose safety and effectiveness can be guaranteed through routine management.

Typical Products: Surgical knives, medical fever-reducing patches, stethoscopes, tongue depressors, medical magnifying glasses, surgical gowns, examination gloves, etc.

Management Requirements: Subject to filing management. Production filing is the responsibility of municipal drug regulatory authorities, and no permit is required for operation.

Class II Medical Devices

Definition: Medical devices with a moderate degree of risk, requiring strict control and management to ensure their safety and effectiveness.

Typical Products: Thermometers, blood pressure monitors, blood glucose meters, medical masks, electrocardiographs, B-ultrasound machines, condoms, etc.

Management Requirements: Subject to provincial registration. Production requires a "Medical Device Production License," and operation requires a "Medical Device Business License."

Class III Medical Devices

Definition: Medical devices with a relatively high degree of risk, requiring special measures for strict control and management to ensure their safety and effectiveness. They are typically used for implantation into the human body or to support or sustain life.

Typical Products: Cardiac pacemakers, artificial joints, vascular stents, extracorporeal shock wave lithotripters, artificial lenses, laser surgical equipment, CT machines, etc.

Management Requirements: Subject to national registration. Production requires national-level approval, and operation requires strict qualification review.

II. Classification Basis for Medical Devices

The classification of medical devices is primarily based on the degree of risk, taking into account the following factors comprehensively:

Intended Use

Class I: Used for routine care or basic diagnosis, such as surgical knives and stethoscopes.

Class II: Used for disease diagnosis, treatment, or monitoring, such as blood pressure monitors and blood glucose meters.

Class III: Used for implantation into the human body, to support or sustain life, or posing a potential high risk to the human body, such as cardiac pacemakers and artificial joints.

Method of Use

Class I: Simple to operate, requiring no professional skills, such as tongue depressors.

Class II: Requires certain professional skills for operation, such as blood glucose meters.

Class III: Complex to use and requires strict training, such as artificial heart valve implantation.

Structural Characteristics

Class I: Simple in structure, such as surgical knives.

Class II: Slightly complex in structure, such as electronic thermometers.

Class III: Complex in structure, such as vascular stents.

Degree of Contact with the Human Body

Class I: Contact with the surface of the human body, such as masks.

Class II: Contact with deep tissues or short-term implantation, such as disposable syringes.

Class III: Long-term implantation into the human body or contact with the circulatory system, such as artificial joints.

Active or Passive Nature

Class I: Mostly passive devices, such as crutches.

Class II: Partially active devices, such as physiotherapy instruments.

Class III: Active devices with high risk, such as X-ray machines.

Duration of Use

Class I: Typically for short-term or one-time use, such as surgical gowns.

Class II: May be used for short-term or medium-term periods, such as medical masks.

Class III: Long-term implantation or use, such as cardiac pacemakers.

Invasiveness

Class I: Non-invasive, such as stethoscopes.

Class II: May be slightly invasive, such as disposable syringes.

Class III: Highly invasive, such as vascular stents.

III. Special Cases and Dynamic Adjustments

Combination Products: Drug-device combination products primarily functioning as medical devices (such as medicated dressings) are directly classified as Class III.

Sterile Products: Medical devices provided in sterile form (such as disposable syringes) are classified no lower than Class II.

Dynamic Adjustments: The National Medical Products Administration dynamically adjusts the classification catalog based on changes in risk. For example, the "Embryo Preimplantation Genetic Testing Kit for Thalassemia," added in 2025, was classified as Class III due to its involvement in genetic testing.