With prosess of
medical reform, medical devices began to become popular.Many investors turn
their attention to this area,medical
equipment is emerging up the industry for expertise in a lot of investors
are not very understanding of this invisibleto invest a certain amount of risk.
Below are we encountered a problem and solution.
23.What is role Clinical medical staff play in the medical device adverse events inspection?
As a medical device adverse events (one of the main body of report, a medical institution is most the use of medical equipment room, also be the main medical device adverse events occurred. At the same time, as a medical institution staff, clinical medical staff has professional background and industry position, can grasp the event first-hand material, and it has good ability to identify. Therefore, clinical and medical personnel in the medical device adverse event monitoring play an important role. Medical personnel to report, analysis medical device adverse events, with enterprise and related departments of the survey, is to make sure the public safety with an important guarantee of soldiers.
24 What is the re-evaluation of medical devices?
Medical equipment re-evaluation refers to safety of medical devices approved for marketing.The effectiveness of re-evaluation, and implementation of corresponding measures of process.
25.What is the function of medical equipment manufacturer in medical devices re-evaluation ?
Medical device manufacturing enterprise is the main body of medical equipment and evaluation, should according to medical equipment product technical structure, quality system requirements set medical equipment to start conditions, evaluation program evaluation and the method; According to carry out the conclusion to evaluation shall, when necessary, be according to relevant provisions of his medical device registration registration procedure.
26 What is the function of the drug regulatory department in medical devices re-evaluation?
The State Food and Drug Administration and provinces, autonomous regions and municipalities food and drug supervision and management department is responsible for overseeing the re-evaluation to check the medical device manufacturer, if necessary, the organization to carry out the re-evaluation of medical devices.
27. What is medical equipment recovery?
Medical equipment recovery. It is to show medical device manufacturing enterprise in accordance with the procedures prescribed by already listed sales of unsafe products, according to procedures prescribed by the take warning, checked, repaired, the new labels, amend the description, software upgrade, replaced, and withdraw, destroyed, eliminate the product of the harm of way behavior. The recovery includes production enterprise voluntary recall and supervision and management departments.
23.What is role Clinical medical staff play in the medical device adverse events inspection?
As a medical device adverse events (one of the main body of report, a medical institution is most the use of medical equipment room, also be the main medical device adverse events occurred. At the same time, as a medical institution staff, clinical medical staff has professional background and industry position, can grasp the event first-hand material, and it has good ability to identify. Therefore, clinical and medical personnel in the medical device adverse event monitoring play an important role. Medical personnel to report, analysis medical device adverse events, with enterprise and related departments of the survey, is to make sure the public safety with an important guarantee of soldiers.
24 What is the re-evaluation of medical devices?
Medical equipment re-evaluation refers to safety of medical devices approved for marketing.The effectiveness of re-evaluation, and implementation of corresponding measures of process.
25.What is the function of medical equipment manufacturer in medical devices re-evaluation ?
Medical device manufacturing enterprise is the main body of medical equipment and evaluation, should according to medical equipment product technical structure, quality system requirements set medical equipment to start conditions, evaluation program evaluation and the method; According to carry out the conclusion to evaluation shall, when necessary, be according to relevant provisions of his medical device registration registration procedure.
26 What is the function of the drug regulatory department in medical devices re-evaluation?
The State Food and Drug Administration and provinces, autonomous regions and municipalities food and drug supervision and management department is responsible for overseeing the re-evaluation to check the medical device manufacturer, if necessary, the organization to carry out the re-evaluation of medical devices.
27. What is medical equipment recovery?
Medical equipment recovery. It is to show medical device manufacturing enterprise in accordance with the procedures prescribed by already listed sales of unsafe products, according to procedures prescribed by the take warning, checked, repaired, the new labels, amend the description, software upgrade, replaced, and withdraw, destroyed, eliminate the product of the harm of way behavior. The recovery includes production enterprise voluntary recall and supervision and management departments.
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