Post-marketing Safety Measures of Medical Devices—Post Marketing Surveillance and Registry—

DOI
  • ISHII Kensuke
    独立行政法人医薬品医療機器総合機構医療機器審査第三部
  • TAWARAGI Tomiko
    独立行政法人医薬品医療機器総合機構安全管理監

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  • 医療機器の市販後安全対策等－PMSとレジストリ－

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Post-marketing surveillance (PMS) enables confirmation of the efficacy and safety of medical devices under clinical conditions that could not be obtained from clinical trials. In addition to producing beneficial clinical information for patients, PMS is important in the planning of post-market safety measures. However, PMS conducted only by private corporations would invariably face various problems. Currently, the development of post-market registries under industry-government-academic collaborations is gaining worldwide importance. Well-designed and high-quality post-market registries may facilitate the implementation of prompt safety measures, optimization of patient care, understanding of the actual performance of medical devices, and reduce the dependence on clinical trials. Japan has already initiated several post-market registries under industry-government-academic collaborations (J-MACS and TAVI registry), but it is hoped that there will be further discussions regarding the utility value of evidence obtained from these registries, with the continued implementation of various other registries in the future.

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