Copy of MHLW MO169 2014 and 2021

[GP233_233]

Hi all, I am currently doing a gap analysis for MDSAP on the updated MHLW MO169 (going from 2014 to 2021) version, I would like to ask what is the best way to get a copy of the two versions. Thank you!

 

[paulag]

Revision of Japanese Medical Device QMS requirements | Pharmaceuticals and Medical Devices Agency

PMDA,pmda

www.pmda.go.jp

 

[GP233_233]

Hey @paulag thank you for responding. This is actually one of the first site I was on to look for the new standard, tho it only provide Chapter 3,4,5 of the 2021 standard, lacking Chapter 1,2,6.

I no longer need MO169 however, hopefully this thread can help other people down the line.

 

[paulag]

Try to run an english translation on this one:
医療機器及び体外診断用医薬品の製造管理及び品質管理の基準に関する省令 | e-Gov法令検索

 

[paulag]

Try to run an english translation on this one:
医療機器及び体外診断用医薬品の製造管理及び品質管理の基準に関する省令 | e-Gov法令検索

It shows the date in Reiwa time (e.g. Reiwa 4), not in our years ( e.g. 2021)

 

[paulag]

It shows the date in Reiwa time (e.g. Reiwa 4), not in our years ( e.g. 2021)

2022 - Reiwa 4
2021 - Reiwa 3
2020 - Reiwa 2
2019 - Reiwa 1 / Heisei 31