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The difference between one, two and three types of medical devices?

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2022-11-24

 

A. Classification of medical devices.
The first category refers to, through routine management is sufficient to ensure the safety and effectiveness of medical devices.
The second category refers to the safety and effectiveness of the medical device should be controlled.
The third category refers to, implanted in the human body; used to support, maintain life; the human body has the potential for danger, the safety and effectiveness of medical devices must be strictly controlled.
Second, the scope of medical equipment license.
1. The operation of Class II and Class III medical device products of legal entities, unincorporated units and branches established by legal entities should apply for a "medical device business license. Except as otherwise provided by the State Food and Drug Administration.
2. Financial leasing of medical equipment products, medical device business enterprises or medical device production enterprises in the enterprise "medical device business enterprise license" or "medical device manufacturer license" set up outside the registered address to operate medical devices, and medical device manufacturers to sell their own products outside the scope of medical devices, should apply for "medical device business enterprise license". 3. unincorporated units to apply for "medical device license", only the second class medical device products or third class medical device products in contact lenses and care solutions.
Third, the difference between Class I, Class II, Class III medical devices.
Class I, Class II and Class III terminology management categories, see medical device supervision and management regulations have relevant provisions. Management from low to high. Medical devices, refers to instruments, equipment, apparatus, materials or other items used in the human body alone or in combination, including the required software; its use on the human body surface and in vivo is not obtained by means of pharmacology, immunology or metabolism, but may have these means involved and play a role in the auxiliary; its use is intended to achieve the following intended purposes.
(1) Prevention, diagnosis, treatment, monitoring, and mitigation of disease;
(2) Diagnosis, treatment, monitoring, mitigation, and compensation for injury or disability;
(3) The study, replacement, and regulation of anatomical or physiological processes;
(4) Pregnancy control.
Medical devices are divided into three categories:
The first category of medical devices are: basic surgical knives "scalpel handles and blades, skin slicing knife, wart removal knife, willow knife, spatula, shaving knife, dander scraper, pick knife, sharp knife, pedicure knife, manicure knife, scalpel, etc.
Class II medical devices: (a) general diagnostic instruments class (6820): thermometers, sphygmomanometers; (b) physical therapy and rehabilitation equipment class (6826): magnetic therapy apparatus; (c) clinical testing and analysis instruments class (6840): home blood glucose analyzer and test strips; (d) operating rooms, emergency rooms, treatment rooms equipment and apparatus class (6854): medical small oxygen machine portable oxygen generator;? (e) medical hygiene materials and dressings category (6864): Quantitative skim cotton, medical skim gauze;? (f) medical polymer materials and products category (6866): condoms, caps, etc.
Class III medical devices.
A, single-use sterile medical devices 1, single-use sterile syringes; 2, single-use infusion set; 3, single-use transfusion set; 4, single-use anesthesia puncture kit; 5, single-use intravenous infusion needle; 6, single-use sterile injection needle; 7, single-use plastic blood bags; 8, single-use blood collection device; 9, single-use burette-type infusion set.
B, orthopedic implants medical devices?1, surgical implants joint prosthesis; (single-use sterile medical devices, hearing aids, contact lenses and care with liquid, in vitro diagnostic reagents, 6846 implantable materials and artificial organs, 6877 interventional devices are excluded), etc.

Keywords：Human Health

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