2022-02-28-世界卫生组织-WHO_global_benchmarking_tool_plus_medical_devices_rev._VI+_MD_ver._1_–_Market_Surveillance_and_Control_58页_695kb

报告摘要

WHO GLOBAL BENCHMARKING TOOL PLUS MEDICAL DEVICES FOR EVALUATION OF NATIONAL REGULATORY SYSTEM OF MEDICAL PRODUCTS MARKET SURVEILLANCE AND CONTROL (MC) is a framework developed by WHO to assess and improve countries' regulatory systems for medical products, focusing on market surveillance and control to ensure product quality, safety, and efficacy.
It encompasses six main indicators (MC01 to MC06) covering legal provisions, organizational structures, human resources, standard procedures, performance monitoring, and transparency communication.
Key areas include preventing and detecting substandard/falsified medical products, regulating import activities, controlling promotional materials, and ensuring traceability through unique identifiers.
Each indicator has sub-indicators with maturity levels (NOT IMPLEMENTED, ONGOING, PARTIALLY, IMPLEMENTED) and requires evidence review like legal documents, guidelines, and records.
WHO references and international standards are used as guidance.
The tool helps countries benchmark their performance, identify gaps, and implement reforms to enhance public health safety.

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