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                    How to distinguish one medical device, two medical devices, three medical devices?
                    time:2020-11-18 13:50:37  click rate:0

                    Pregnancy control; To provide information for medical or diagnostic purposes by examining samples from the human body.

                    Medical devices have different equipment and models for different diseases. Medical devices not only have different classifications in this respect, but also can be divided into: Type I, type II and type III medical devices. This category may be difficult to distinguish. What kind of devices does each category refer to? The first category refers to the medical devices that can ensure their safety and effectiveness through routine management. The second kind is to point to, the medical device that should try to control to its safety, effectiveness. The third category is implant; To support or sustain life; Medical apparatus and instruments that are potentially dangerous to human body and must be strictly controlled for their safety and effectiveness.

                    Each category of medical devices mentioned above has its business scope, and the business requirements of each category should be strictly observed: For example, the legal entity, the unlegal entity and the branch established by the legal entity shall apply for a Medical Device Business Enterprise License. Except as otherwise stipulated by the State Food and Drug Administration; Financing lease of medical equipment products, medical equipment management enterprise or medical device manufacturing enterprise in the enterprise the medical equipment management enterprise license or medical device manufacturing enterprise license shall set up outside the registered address of the premises of medical equipment products, as well as the medical device manufacturing enterprise, sales produced products outside the scope of medical devices shall be bidding for the medical equipment business license; An unincorporated entity applying for a Medical Device Business License shall be limited to contact lenses and nursing liquid in class II or Class III medical device products.


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