MHLWMinisterialOrdinanceNo46169in2004-BSI 系统标签: mhlwministerialordinancebsi OrdinanceonStandardsforManufacturingControlandQualityControlofMedicalDevicesandInVitroDiagnosticReagents(IncludingRevisionbyMHLWMinisterialOrdinanceNo.87DatedJuly30,2014)-1-MHLWMinisterialOrdinanceNo.169in2004December17,2004RevisionbyMHLWMiniste...
MHLW Ministerial Ordinance 169 (MHLW MO169) was initially published in 2004 to ensure that Japanese medical device QMS requirements are harmonized with ISO13485:2003. On March 26, 2021, MHLW MO169 was revised to align with the updated ISO13485:2016, with a transition period of3 years ...
12.“Cell/tissue-based medical device”throughout this Ministerial Ordinance means the medical device composed of human or animal cells or tissue. 13.“Donor”throughout this Ministerial Ordinance means the person who donates the cells or tissue that serves as the materials for the cell/tissue-bas...
MHLW Ministerial Ordinance 169 (MHLW MO169) was initially published in 2004 to ensure that Japanese medical device QMS requirements are harmonized with ISO13485:2003. On March 26, 2021, MHLW MO169 was revised to align with the updated ISO13485:2016, with a transition period of3 years for...