Drugdu.com expert's response:

Class II medical devices refer to medical devices with moderate risk that require strict control and management to ensure their safety and effectiveness. Below is a detailed explanation of Class II medical devices:

I. Definition and Risk Level

Definition: Class II medical devices are those whose safety and effectiveness should be controlled. These devices are typically used for the prevention, diagnosis, monitoring, treatment, or alleviation of diseases in human organs, tissues, or body fluids outside the body, employing various technological means and potentially posing a moderate risk to humans.

Risk Level: The risk level of Class II medical devices falls between that of Class I low-risk medical devices and Class III high-risk medical devices. Class I medical devices have a low degree of risk and can be managed through routine measures to ensure their safety and effectiveness. In contrast, Class III medical devices carry a higher risk and require special measures for strict control and management.

II. Regulatory Requirements

Registration Management: Class II medical devices are subject to product registration management, with approval, issuance, and registration overseen by the food and drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government. When applying for the registration of a Class II medical device, the applicant must submit registration application materials to the drug regulatory department of the local provincial, autonomous regional, or municipal government, including product risk analysis documents, product technical requirements, product inspection reports, and clinical evaluation documents.

Production and Business Licensing: Manufacturers of Class II medical devices must obtain a production license issued by the National Medical Products Administration (NMPA) to demonstrate their qualification to produce such devices. Similarly, sales enterprises of Class II medical devices must also obtain the corresponding business license or file for备案 (record-filing) to prove their eligibility to sell these devices.

Technical Requirements and Product Labeling: Class II medical devices must comply with relevant national technical requirements and standards to ensure their safety and effectiveness. Additionally, these devices must be labeled with relevant information on the product, such as the manufacturer's name, specifications and model, production date, and expiration date, to facilitate identification and traceability by consumers and regulatory authorities.

Safety Supervision: Class II medical devices require regular safety supervision and testing to ensure their safety and effectiveness. Regulatory authorities will conduct regular inspections and sampling tests on the production, business, and use links of Class II medical devices, and take enforcement actions and recalls for non-compliant medical devices.

III. Common Products

Class II medical devices encompass a wide range of products, including but not limited to the following:

Diagnostic and Monitoring Equipment: Such as blood pressure monitors, glucometers, thermometers, electrocardiographs, electroencephalographs, microscopes, and biochemical analysis systems.

Treatment and Rehabilitation Equipment: Such as hearing aids, nebulizers, ultrasonic disinfection devices, physical therapy and rehabilitation equipment, and traditional Chinese medicine instruments.

Surgical Instruments and Equipment: Such as basic surgical instruments, microscopic surgical instruments, neurosurgical instruments, ophthalmic surgical instruments, as well as related operating room, emergency room, and consultation room equipment and appliances.

Medical Materials and Dressings: Such as medical suturing needles, non-absorbable sutures, medical sanitary materials, and dressings.

Others: Such as medical X-ray equipment, medical X-ray accessory equipment and components, medical high-energy ray equipment, and medical radionuclide equipment.