Evaluation of the Effectiveness of the Notification Process in the Area of Health Products

Health Policy and Technology(2019)

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摘要
•The adequacy of the company that makes notifications of techno vigilance to the good manufacturing practices in force and the registration of the product in question at the sanitary authority.•Ishikawa diagram for root cause assessment for underreporting and non-reporting.•The concepts: sample, technical complaint, adverse effects, notification, degree of risk, and the dimensions knowledge and attitude.•Evaluation of the level of implementation of techno-surveillance in companies and the impact on health products complaints.
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关键词
Benchmarking,Health products,Techno vigilance,Health legislation,Risk management,Monitoring
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