Medical device category 1、Category II、Classification criteria for three categories_Classification

Medical device category 1、Category II、Classification criteria for three categories_Classification 1、Classification of medical devices： The first category refers to，Regular management is sufficient to ensure its security、effectiveness of medical devices。 The second category refers to，to its security、Medical devices whose effectiveness should be controlled。 The third category refers to，Implanted into human body;for support、sustain life;Potentially dangerous to human body，to its security、Medical devices whose effectiveness must be strictly controlled。

two、Medical device license scope：

1. .Legal entities operating Class II and III medical device products、Unincorporated entities and branches established by legal entities shall apply for a "Medical Device Business Enterprise License"。Unless otherwise specified by the State Food and Drug Administration。
2. Financial leasing medical device products、A medical device operating enterprise or medical device manufacturing enterprise shall set up a business location to sell medical device products in a place other than the registered address stated in the enterprise's "Medical Device Operating Enterprise License" or "Medical Device Manufacturing Enterprise License"，and medical device manufacturers selling medical device products beyond the scope of their own products.，Should apply for a "Medical Device Business Enterprise License"。
3. Unincorporated units apply for a "Medical Device Business Enterprise License"，Only contact lenses and care solutions included in Category II medical device products or Category III medical device products。 three、A category、Category II、The difference between the three types of medical devices： A category，Category II and III terminology management categories，See the Medical Device Supervision and Administration Regulations for relevant provisions.。Management from low to high。

medical device，Refers to instruments used on the human body alone or in combination、equipment、utensil、materials or other items，Includes required software;Its effects on the human body surface and inside the body are not pharmacological、Obtained by immunological or metabolic means，But these means may be involved and play a certain supporting role.;Its use is intended to achieve the following intended purposes： (1)prevention of disease、diagnosis、treat、guardianship、ease; (2)Diagnosis of injury or disability、treat、guardianship、ease、compensate; (3)the study of anatomy or physiological processes、substitute、adjust; (4)pregnancy control。

Medical devices are divided into three categories: Class I medical devices include：Basic surgical knives "Scalpel handle and blade、Skin grafting knife、wart peeling knife、lancet、Blade、razor、dandruff scraper、Pick a knife、sharp knife、Shukyakuto、manicure knife、Scalpels, etc.》 Class II medical devices：(a)General diagnostic equipment(6820)：thermometer、sphygmomanometer;( b)Physical therapy and rehabilitation equipment(6826)：Magnetic therapy equipment; (c)Clinical testing and analysis instruments(6840)：Home-use blood glucose analyzer and test strips; (d)operating room、emergency room、Clinic equipment and appliances(6854)：Medical small oxygen concentrator portable oxygen generator; (e)Medical hygiene materials and dressings(6864)：Use absorbent cotton、Medical skim gauze; (f)Medical polymer materials and products(6866)：condom、Contraceptive caps, etc. Class III medical devices：A、Disposable sterile medical devices

1. Disposable sterile syringe;
2. Disposable infusion set;
3. Disposable blood transfusion set;
4. Disposable anesthesia puncture kit;
5. Disposable intravenous infusion needle;
6. Disposable sterile injection needle;
7. Disposable plastic blood bags;
8. Disposable blood collection device;
9. Disposable burette infusion set。

B、Orthopedic Implants Medical Devices

1. surgical implant joint prosthesis;(Disposable sterile medical devices、hearing aid、Contact lenses and care solutions、In vitro diagnostic reagents、6846Implant materials and artificial organs、6877Except for interventional devices)Wait four、Business premises、Warehouse area

Require

：

1. Business Category II、Class III medical device products，The usable area of ​​the business premises should be no less than 40 square meters，The usable area of ​​the business premises of a branch of a legal entity shall be no less than 25 square meters.(Except for those set up across districts and cities);Dealer of hearing aids，The usable area of ​​the business premises should not be less than 25 square meters;Those who deal in contact lenses and care solutions，The usable area of ​​the business premises should not be less than 10 square meters。
2. Business Category II、Class III medical devices(hearing aid、Contact lenses and care solutions、Disposable sterile medical device products in vitro diagnostic reagents、6846Implant materials and artificial organs、6877Except for interventional devices)，The usable area of ​​the warehouse should be no less than 30 square meters;Dealing in disposable sterile medical equipment，The warehouse should be in the same building，The usable area should be no less than 200 square meters。
3. Legal entity branch(Except for those established across districts and cities)and those specializing in medical devices and equipment，No need to set up a separate warehouse，However, it should be a legal entity or a manufacturer authorized to operate products.(Including import general agent)Unified procurement and distribution of original seals、Unified quality management、Commitments such as installation and after-sales service，And the registration certificate of the specialized products、Authorization documents and other proofs。
4. Dealing in hearing aids or contact lenses and their care solutions，No need to set up a warehouse，But there should be a special counter for storage。
5. In principle, the declared business premises and warehouse shall be located nearby within the same administrative area.，and shall not be located in residential buildings、force、public security、Inside the armed police camp。

five、Enterprise personnel qualifications

Require

：

1. Operating third-class medical device products，quality manager、The person in charge of the quality organization should have a nationally recognized、Majors related to product management(medical device、biomedical engineering、mechanical、Electronics, etc.)College degree or above or intermediate technical title or above in related majors。

Dealing in disposable sterile medical equipment,There should also be at least one internal auditor holding a medical device quality management system internal auditor certificate.(The quality manager shall not concurrently serve as)。

1. Those operating Class II medical device products，quality manager、The person in charge of the quality organization should have a nationally recognized、Majors related to product management(medical device、biomedical engineering、mechanical、Electronics, etc.)Technical secondary school degree or above or junior technical title or above in related majors。
2. Business Category II、Class III medical device products，Technical training and after-sales service personnel(medical device、biomedical engineering、mechanical、electronic)etc. should have a technical secondary school degree or above or a junior technical title or above in a major related to the products they operate.。
3. Those who deal in hearing aids or contact lenses and care solutions，The quality manager shall be a third-party organization recognized by the state or a production enterprise authorized to operate.(Including import general agent)Contact lens fitting technology training。
4. Quality managers and heads of quality organizations are not allowed to hold concurrent jobs。

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