![]() Hence, Marketing Authoriation Holders etc. MHLW MO169 was revised to align with ISO13485:2016 in March 26, 2021. The additional requirements to ISO13485:2003 were moved to the third chapter of the ordinance.Ģ017: Requirements for re-manufacturing single-use device (R-SUD) were incorporated in the ordinace.Ģ021: The second chapter of the ordinance was revised to align with ISO13485:2016. ![]() Revision history, MHLW MO169 (only main revision) 2004: Initial version published.Ģ014: The second chapter of the ordinance was revised to more align with ISO13485:2003. The ordinace has been revised several times since its establishment (see the following). MHLW MO169 was initially established in 2004 in order to make the medical device QMS requirements harmonized with international standard, ISO13485:2003. 169 (2004) titled "the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics" (hereinafter refered to as MHLW MO169). The Japanese medical device Quality Management System requirements are stipulated in MHLW Ministerial Ordinance No.
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