MHLW MO169 日本医疗器械质量管理体系要求 下载积分: 1000 内容提示: Tentative translation ver. 3.1 (as of 5 September 2005)1 MHLW Ministerial Ordinance No. 169, 2004 In accordance with the provisions of Item (4) of Paragraph 2 of Article 14 and Item (4) of Paragraph 2 of Article 14 ...
OrdinanceonStandardsforManufacturingControlandQualityControlofMedicalDevicesandIn VitroDiagnosticReagents (IncludingRevisionbyMHLWMinisterialOrdinanceNo.87DatedJuly30,2014) -1- MHLWMinisterialOrdinanceNo.169in2004 December17,2004 RevisionbyMHLWMinisterialOrdinanceNo.87DatedJuly30,2014 OrdinanceonStandardsforManufacturing...
MHLW MO169 has transitioned 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 tran...
Ministerial Ordinance 169. (2004). MHLW ministerial ordinance 169 on standards for manufacturing control and quality control for medical devices and in-vitro diagnostic reagents. Retrieved June 1, 2012, fromhttp://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf ...
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 f...