Japan MHLW Ordinance No 94. (QMS structure Regulation)

[pdzip2]

Can anyone make an english copy of the MHLW ordinance No 94 (Taisei Syorei or QMS Structure Regulation available for download)?

It is referenced in an Emergo paper of October 2016 titled "Japan Ordinance 169 and Medical Device QMS Requirements" with subtitle Conformity assessment routes and updated QMS requirements.

Much obliged to the forum if /when it provides the answer.

 

[Marc]

A quick "Bump". My Thanks in advance to anyone who can help with this unanswered question. And, should you be browsing threads and find this one, and it still has no reply, if you can help we will all appreciate it.