Japan MHLW Ordinance 36 Good Clinical Practice for Medical Devices, 3/09

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Japan’s Ministerial Ordinance on Good Clinical Practice for Medical Devices was published to provide standards which serve as the GCP for medical devices to ensure the scientific quality of clinical trials and the reliability of clinical trial data while protecting and promoting the rights, safety, and welfare of human subjects.

For computer topics, refer to:

• Chapter II, Article 10 Prior Submission of Documents to the Head of Medical Institution
• Chapter II, Article 12 Outsourcing Duties