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The State Council passes the draft amendment to the Regulations for the Supervision and Administration of Medical Devices
Time:2016-8-2    Browers:2871
After the comprehensive revision to the original Regulations, the draft amendment to the Regulations consists of 80 articles in eight chapters. The draft amendment adjusted the definition and classification rules of medical devices; further improved the authority management for product registration, approval or record keeping of manufacturing and distribution of medical devices; set up measures for quality supervision and risk control during the manufacturing of medical devices; established systems for adverse event monitoring, tracing and recall of medical devices; further strenthened inventory management, examination and acceptance system, and certificate claim in the distribution of medical devices; added relevant requirements on supervision of the medical devices in use; and increased the punishments for illegal activities.