The first category refers to medical devices whose safety and effectiveness can be ensured through routine management.

The second category refers to medical devices whose safety and effectiveness should be controlled.

The third category refers to medical devices that are implanted in the human body to support and maintain life; they are potentially dangerous to the human body and their safety and effectiveness must be strictly controlled.

　　3. Non-legal entities applying for a Medical Device Business License are limited to operating registered Class II medical devices or contact lenses and care solutions in Class III medical devices.

　The management categories of the terms Class I, Class II and Class III are subject to the relevant provisions of the Medical Device Supervision and Administration Regulations. Management is from low to high. Medical devices refer to instruments, equipment, appliances, materials or other items used on the human body alone or in combination, including the required software; their effects on the human body surface and body are not obtained by pharmacological, immunological or metabolic means, but these means may participate and play a certain auxiliary role; their use is intended to achieve the following intended purposes:

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

　　(2) diagnosis, treatment, monitoring, relief, and compensation for injury or disability;

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

　　(4) Pregnancy control. Medical devices are divided into three categories:

　　There are many categories and varieties of medical device products. There are more than 30 categories in terms of major categories, more than 3,000 varieties and more than 10,000 specifications. In order to effectively supervise and manage medical device products, the state implements classification management of these products into categories one, two and three. The principles of these three categories and the main categories they include are as follows:

　　① Category 1

　　Medical devices that can be guaranteed to be safe and effective through routine management, such as most surgical instruments, stethoscopes, medical X-ray films, medical X-ray protection devices, fully automatic electrophoresis apparatus, medical centrifuges, slicers, dental chairs, boiling sterilizers, gauze bandages, elastic bandages, adhesive plasters, band-aids, cupping devices, surgical gowns, surgical caps, masks, urine collection bags, etc.

　　② Category 2

　　Medical devices whose safety and effectiveness should be controlled, such as thermometers, sphygmomanometers, hearing aids, oxygen concentrators, condoms, acupuncture needles, ECG diagnostic instruments, non-invasive monitoring instruments, optical endoscopes, portable ultrasound diagnostic instruments, fully automatic biochemical analyzers, constant temperature incubators, dental comprehensive treatment instruments, medical absorbent cotton, medical absorbent gauze, etc.

　　③The third category

　　Medical devices that are implanted in the human body or used to support life, are potentially dangerous to the human body, and their safety and effectiveness must be strictly controlled. Such as implantable cardiac pacemakers, extracorporeal shock wave lithotripsy, invasive patient monitoring systems, artificial lenses, invasive endoscopes, ultrasonic scalpels, color ultrasonic imaging equipment, laser surgical equipment, high-frequency electric knives, microwave therapeutic devices, medical magnetic resonance imaging equipment, X-ray treatment equipment, X-ray machines above 200mA, medical high-energy equipment, artificial heart-lung machines, internal fixation equipment, artificial heart valves, artificial kidneys, respiratory anesthesia equipment, disposable sterile syringes, disposable infusion sets, blood transfusion sets, CT equipment, etc.

　　1. For those who operate Class II and Class III medical devices, the usable area of ​​the business premises shall not be less than 40 square meters; the usable area of ​​the business premises of the branch of a legal entity shall not be less than 25 square meters (except for those set up across municipalities); for those who operate hearing aids, the usable area of ​​the business premises shall not be less than 25 square meters; for those who operate contact lenses and care solutions, the usable area of ​​the business premises shall not be less than 10 square meters.

　　2. For those who operate Class II and Class III medical devices (except hearing aids, contact lenses and care solutions, disposable sterile medical device products, in vitro diagnostic reagents, 6846 implant materials and artificial organs, and 6877 interventional devices), the warehouse area should be no less than 30 square meters; for those who operate disposable sterile medical devices, the warehouse should be in the same building and the area should be no less than 200 square meters.

　　3. Branches of legal entities (except those established across municipalities) and those specializing in medical devices and equipment do not need to set up separate warehouses, but they must have commitments on unified procurement and distribution, unified quality management, installation and after-sales service, etc., stamped with the original seal of the legal entity or the manufacturer of the authorized products (including the import general agent), as well as registration certificates, authorization documents and other certificates of the specialized products.

　　4. If you are engaged in the business of hearing aids or contact lenses and their care solutions, you do not need to set up a warehouse, but you must have a special counter for storage.

　　5. In principle, the business premises and warehouses reported shall be located nearby within the same administrative area, and shall not be located in civilian residences, military, public security, or armed police barracks.

　1. For those who operate Class III medical devices, the quality manager and the person in charge of the quality organization shall have a nationally recognized college degree or above in a major related to the products they operate (medical devices, biomedical engineering, machinery, electronics, etc.) or a technical title of intermediate or above in a related major. For those who operate disposable sterile medical devices, there shall also be one or more internal auditors who hold a medical device quality management system internal auditor certificate (the quality manager shall not concurrently hold this position).

　　2. For those who operate Class II medical devices, the quality manager and the person in charge of the quality organization shall have a nationally recognized technical secondary school degree or above in a major related to the products they operate (medical devices, biomedical engineering, machinery, electronics, etc.) or a junior technical title or above in a related major.

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

　　4. For those who operate hearing aids or contact lenses and care solutions, the quality manager shall receive contact lens fitting technical training from a third-party organization recognized by the state or an authorized manufacturer (including import general agents).

　　5. Quality managers and heads of quality organizations are not allowed to hold part-time positions.

　　There are too many medical device companies, their scale is too small, and their quality levels are uneven. Nowadays, simplifying the access procedures will inevitably add more tasks to post-market supervision. It is necessary to establish a quality management system, strictly implement warehouse management, circulation management, etc., but the risk of operating varieties is lower. No matter what the criteria are, they must comply with the requirements of the "Medical Device Business Quality Management Specifications".