Thursday, April 9, 2009

JPAL Laws, Ordinances and Notifications

The Pharmaceutical Affairs Law (Law No. 145 Established as of August 10, 1960; Law No. 87 Revised as of July 26, 2005)MHLW Ministerial Ordinance No. 36 Clinical Tests for Medical Devices (hereinafter referred to as "Medical Device GCP" or “JGCP”)
YAKUSHOKUKIHATSU No. 0720005 Administration of Good Clinical Practice for Medical Devices
YAKUSHOKUKIHATSU No. 070720 Essential documents for criteria concerning clinical tests for medical devices
YAKUSHOKUHATSU No. 0720004 Criteria for Clinical Trials for Medical Devices
YAKUSHOKUHATSU No. 0331006 Handling of clinical study data based on clinical study that is carried out in a foreign country
MHLW Administrative Correspondence from June 23, 2006 Q&A on the Handling of Tests Records from Clinical Studies on Medical Devices Conducted Overseas

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