Japan MHLW Ordinance 37 Good Laboratory Practice for Nonclinical Safety Studies for Medical Devices, 6/08
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Japan’s Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies for Medical Devices was published to provide the GLP standards for conducting nonclinical safety studies of medical devices at test facilities or test sites using test systems and data.
This 1997 ordinance (last amended in 2008) was made available in English in 2012.
There are expectations for handling raw data, records and reports throughout the ordinance.
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FDA 21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies
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Japan MHLW Ordinance 21 Good Laboratory Practice for Nonclinical Safety Studies of Drugs, 6/08
Japan’s 2008 Ministerial Ordinance provides GLP standards for conducting nonclinical safety studies of drugs at test facilities or test sites.
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