1. The legal person units, unincorporated units and branches established by legal person units that deal in the second and third types of medical device products shall apply for the "Medical Device Operating Enterprise License". Except as otherwise provided by the State Food and Drug Administration.
2. Financial leasing of medical device products, medical device operating companies or medical device manufacturers setting up business premises to operate medical services in places other than the registered address specified in the company’s "Medical Device Operating Enterprise License" or "Medical Device Manufacturing Enterprise License" For medical device products and medical device products outside the scope of self-produced products sold by medical device manufacturers, they should apply for a "Medical Device Operating Enterprise License."
3. Unincorporated units applying for the "Medical Device Operating Enterprise License" are limited to operating contact lenses and nursing fluids in the second category of medical device products or the third category of medical device products.
Three, the difference between the first class, the second class, and the third class medical devices
Type 1, Type 2, and Type 3 term management categories, see the relevant provisions of the Medical Device Supervision and Administration Regulations. Management 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 functions on the surface and in the body of the human body are not obtained by pharmacological, immunological or metabolic means , But these means may participate and play a certain auxiliary role; its use is intended to achieve the following expected purposes:
(1) Prevention, diagnosis, treatment, monitoring and alleviation of diseases;
(2) Diagnosis, treatment, monitoring, mitigation, and compensation for injury or disability;
(3) Research, substitution, and adjustment of anatomical or physiological processes;
(4) Pregnancy control. Medical devices are divided into three categories:
The first category of medical equipment includes: basic surgical knives "scalpel handles and blades, skin knives, wart peeling knives, lancets, spatulas, razors, dander scrapers, picking knives, front knives, pedicure knives , Manicure knife, scalpel, etc.".
The second category of medical equipment: (a) General diagnostic equipment (6820): thermometers and sphygmomanometers; (b) Physiotherapy and rehabilitation equipment (6826): Magnetic therapy equipment; (c) Clinical inspection and analysis equipment (6840) : Household blood glucose analyzers and test strips; (d) Equipment and appliances for operating rooms, emergency rooms, and clinics (6854): Portable oxygen generators for medical small oxygen generators; (e) Medical sanitary materials and dressings (6864) ): Use absorbent cotton, medical absorbent gauze; (f) Medical polymer materials and products (6866): condoms, contraceptive caps, etc.
The third category of medical devices: A. Sterile medical devices for single use 1. Sterile syringes for single use; 2. Infusion set for one-time use; 3. Blood transfusion set for one-time use; 4. One-time use anesthesia puncture kit; 5 1. Disposable intravenous infusion needle; 6. Disposable sterile injection needle; 7. Disposable plastic blood bag; 8. Disposable blood collection device; 9. Disposable burette type infusion set. B. Orthopedic implant medical device 1. Surgical implant joint prosthesis; (disposable sterile medical devices, hearing aids, contact lenses and nursing fluids, in vitro diagnostic reagents, 6846 implant materials and artificial organs, 6877 intervention Except equipment), etc.
