Medical Devices in Japan - Conformity of QMS to ISO 13485

[JeantheBigone]

I'm looking for confirmation of something I think is the case with regard to conformity of the QMS of a manufacturer marketing a device in Japan to ISO 13485. Since I can't read Japanese, I'm not 100 % positive that the following is true, but here goes......

Japan does not currently require conformity to ISO 13485, instead it has its own QMS which is described in MO 169. They are in the process of harmonizing, but for now it is not an issue if a manufacturer of a medical device marketed in Japan does not have ISO 13485.

Is that correct?

 

[v9991]

your assessment seems to be correct;

specific details @
Revision of Japanese Medical Device QMS requirements | Pharmaceuticals and Medical Devices Agency
https://www.pmda.go.jp/files/000207980.pdf

Japanese medical device regulators coordinating ISO 13485:2016 and MHLW Ordinance No. 169 quality management system requirements


https://www.safetyweb.co.jp/files/medical_equipment/mhlw_no169_20140730.pdf

just in case if you haven't already seen them..