Medical device adverse events, refers to the approved marketing of the quality of medical devices in the normal use of the situation occurs, resulting in or likely to lead to human injury of all kinds of harmful events.
Medical device adverse event monitoring, refers to the process of discovery, reporting, evaluation and control of medical device adverse events.
Medical device re-evaluation, refers to the approval of the safety and effectiveness of medical devices on the market to re-evaluate, and implement the corresponding measures of the process.
Serious injury means one of the following:
(a) life-threatening;
(b) resulting in permanent injury to the function of the organism or permanent damage to the structure of the organism;
(c) medical measures must be taken in order to avoid the above permanent injury or damage.
Medical and health institutions refer to medical institutions and other health institutions subordinate to the competent health authorities that have obtained a Medical Institution Practice License in accordance with the provisions of the Regulations on the Administration of Medical Institutions.