![]() ![]() ![]() Japanese Law Translation (English translation of PMD Act is searchable on the linked webpage.Standards for Re-manufactured Single-use Medical Devices.Tentative translation of MHLW MO1 (Regulations for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices).Manufacturers shall comply with these requirements as well as MHLW MO169 Chapter 5-2, when they manufacture R-SUDs. The followings are translation of the requirements for R-SUDs other than MHLW MO169. Tentative translation of MHLW MO169 Chapter 5-2, as revised in 2021.Tentative translation of MHLW MO169 Chapter 5, as revised in 2021.Tentative translation of MHLW MO169 Chapter 4, as revised in 2021.The followings are translation of the requirements. The product specific requirements of MHLW MO169 are stipulated in the chapter 4, 5,and 5-2 of the ordinance. Tentative translation of MHLW MO169 Chapter 3, as revised in 2014 Tentative translation of MHLW MO169 Chapter 3, as revised in 2021 The addtional requirements of MHLW MO169 are stipulated in the third chapter of the ordinance. MHLW MO169, as revised in 2014 (Previous version)Ĭomparison table between ISO13485:2003 and MHLW MO169 Chapter 2, as revised in 2014.MHLW MO169, as revised in 2021 (Current version)Ĭomparison table between ISO13485:2016 and MHLW MO169 Chapter 2, as revised in 2021.The followings are comparison table between ISO13485 and MHLW MO169 Chapter 2. The requirements are aligned with ISO13485. Main requirements of MHLW MO169 are stipulated in the second chapter of the ordinance. ![]() The worlds only female urinary incontinence device an inflatable, can provide quantitative data progression of the patients condition to the doctor. and Registered Manufacturing Sites must comply with the revised ordinance by March 25, 2024. Incontrol Medical founded in 2010 by the CEO Herschel 'Buzz' Peddicord, design and manufacturing control of urinary incontinence device patents. 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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