Complete Catalogue of Class I, II, and III Medical Devices

1、 Classification of medical devices

The first type is medical devices with low risk levels, and implementing routine management can ensure their safety and effectiveness.

The second type is medical devices with moderate risk that require strict control and management to ensure their safety and effectiveness.

2、 Scope of Medical Device License and Production Conditions

1. The first category of medical devices is subject to product registration management, while the second and third categories of medical devices are subject to product registration management.

2. The registrant and filer of medical devices shall strengthen the quality management of the entire life cycle of medical devices, and bear the responsibility for the safety and effectiveness of traditional Chinese medicine medical devices throughout the development, production, operation, and use process in accordance with the law.

3. The filing of Class I medical device products and the application for registration of Class II and Class III medical device products shall submit the following materials:

（1） Product risk analysis data;

（2） Product technical requirements;

（3） Product inspection report;

（4） Clinical evaluation data;

（5） Product manual and label sample;

（6） Quality management system documents related to product development and production;

（7） Other documents required to prove the safety and effectiveness of the product.

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4. To apply for the registration of Class II medical device products, the registration applicant shall submit the registration application materials to the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the central government where they are located. To apply for registration of Class III medical device products, the applicant shall submit registration application materials to the drug regulatory department of the State Council.

3、 Catalogue of Class I, II, and III medical devices

The management categories of Class I, Class II, and Class III terms are subject to relevant provisions in the Regulations on the Supervision and Administration of Medical Devices. Manage from low to high. Medical devices refer to instruments, equipment, appliances, materials, or other items used alone or in combination with the human body, including required software; Its effects on the surface and body of the human body are not obtained through pharmacological, immunological, or metabolic methods, but these methods may be involved and play a certain auxiliary role; Its use aims to achieve the following expected purposes:

(1) Prevention, diagnosis, treatment, monitoring, and mitigation of diseases;

(2) Diagnosis, treatment, monitoring, relief, and compensation for injuries or disabilities;

(3) Research, substitution, and regulation of anatomical or physiological processes;

(4) Pregnancy control.

Medical devices are divided into three categories:

The first type of medical equipment includes: basic surgical knives, such as surgical handle and blade, skin knife, wart stripping knife, willow blade, shovel, shaver, dandruff scraper, pick knife, sharp knife, foot trimmer, nail trimmer, dissecting knife, etc

Second category medical devices:

(a) Ordinary diagnostic instruments (6820): thermometers and blood pressure monitors;

(b) Physical therapy and rehabilitation equipment (6826): magnetic therapy equipment;

(d) Operating room, emergency room, diagnosis and treatment room equipment and appliances (6854): medical small oxygen concentrators, handheld oxygen generators;

(e) Medical hygiene materials and dressings (6864): use skim cotton and medical skim gauze;

(f) Medical polymer materials and products (6866): condoms, contraceptive caps, etc

Third category medical devices:

A. Disposable sterile medical devices

1. Disposable sterile syringe;

2. Disposable infusion set;

3. Disposable blood transfusion device;

4. Disposable anesthesia puncture kit;

5. Disposable intravenous infusion needles;

6. Disposable sterile injection needles;

7. Disposable plastic blood bags;

8. Disposable blood collection device;

9. Disposable burette infusion set.

10. Orthopedic implants and medical devices

4、 Requirements for the area of medical device business premises and warehouses

1. For the operation of Class II and Class III medical device products, the operating area of the business premises shall not be less than 40 square meters, and the operating area of the branch of the legal entity shall not be less than 25 square meters (except for those set up across districts and cities); For those who operate hearing aids, the operating area of the premises should not be less than 25 square meters; For those who operate contact lenses and care liquids, the operating area should not be less than 10 square meters.

2. For the operation of Class II and Class III medical devices (excluding hearing aids, contact lenses and nursing liquids, disposable sterile medical device products, in vitro diagnostic reagents, 6846 implant materials and artificial organs, and 6877 intervention equipment), the warehouse usage area should not be less than 30 square meters; For the operation of disposable sterile medical devices, the warehouse should be located in the same building, and the usage area should not be less than 200 square meters.

3. For branch offices of legal entities (excluding those established across districts and cities) and specialized medical devices and equipment, separate warehouses may not be established, but they should have commitments related to unified procurement and distribution, unified quality management, installation, and after-sales service stamped with the original seal of the legal entity or authorized production enterprise (including import general agents), as well as certificates of registration and authorization for the specialized products.

4. For those who operate hearing aids or contact lenses and their care solutions, there may not be a warehouse, but there should be a dedicated counter for storage.

5. The declared business premises and warehouses should be set up nearby within the same administrative area, and should not be located in civilian residential areas, military units, public security, or armed police camps.

5、 Requirements for Personnel Qualification of Medical Device Enterprises

1. For those engaged in the operation of Class III medical device products, the quality manager and the person in charge of the quality institution shall have a nationally recognized college degree or above in a major (medical device, biomedical engineering, machinery, electronics, etc.) related to the operation of the product, or an intermediate or higher technical title in a related major. For the operation of disposable sterile medical devices, there should also be one or more internal auditors holding the certificate of medical device quality management system internal auditor (not concurrently held by the quality management personnel).

2. For those engaged in the operation of Class II medical device products, the quality manager and the person in charge of the quality institution shall have a nationally recognized vocational school diploma or above in the relevant majors (medical devices, biomedical engineering, machinery, electronics, etc.) related to the operation of the product, or a junior technical title or above in the relevant major.

3. For those who operate Class II and Class III medical device products, technical training and after-sales service personnel (medical devices, biomedical engineering, machinery, electronics) should have a vocational school diploma or above or a junior technical title related to the products they operate.

4. For those who operate hearing aids, contact lenses, and care liquids, the quality management personnel shall receive training on contact lens fitting technology from nationally recognized third-party organizations or authorized production enterprises (including import agents).

5. The quality manager and the person in charge of the quality organization are not allowed to work part-time.