Medical equipment management regulations lead to different understanding

Our products for medical devices has strict management standards which is not the same for different types of medical equipment management requirements. It has a very different animal x-ray machines and blood pressure monitors. Medical Devices Regulations "in the management of medical equipment category from low to high to be divided into three categories, the higher category, the safety of the product, the higher the validity claims. Implemented in 2004, "Medical Device Registration clear principles of classification and approval by management category, that is, within the first medical device registration (food) drug regulatory department review of certification by the municipal districts; within the ground class II Medical Device provinces, autonomous regions and municipalities (food) drug regulatory department review of certification; domestic Class III medical devices by the State food and Drug Administration review of certification.

Medical Device Registration "departmental rules and regulations of the detailed requirements of the Medical Device Registration, Article 43 states:" (food) drug regulatory department of the municipal districts over the place in violation of the health care of the implementation of the provisions of these Measures Device Registration, by its superior (food) drug supervision and administration department shall order it to make corrections; overdue correction, revocation of the medical device registration certificate of superiors (food) drug regulatory department can direct announcement.

 To sum up, the product can no certificate of registration of medical devices handle critical look at the medical equipment registration certificate is revoked, is not revoked before legal products. Course, law enforcement officers found that this is the case, by the department documents, briefing to the food and drug regulatory authorities to make administrative licensing decision ultra vires, to facilitate their timely correction of errors; overdue, can inform their superiors did not respond food and drug regulatory authorities.

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