Looking for English Copy of MHLW 169 regulation

[Sue789]

Hi All,

I am looking for an English mapping of Chapter 2 the clauses against ISO 13485. Specifically I am looking for the Article numbers against the ISO clause.

In the process of updating my QMS for MDSAP and the links appear to be broken that I have tried or are in Japanese only.

Thanks in advance .
Sue

 

[fialor]

Hi All,

I am looking for an English mapping of Chapter 2 the clauses against ISO 13486. Specifically I am looking for the Article numbers against the ISO clause.

In the process of updating my QMS for MDSAP and the links appear to be broken that I have tried or are in Japanese only.

Thanks in advance .
Sue

Sue789, here is a link to the PMDA website. It has a couple of links, one of which takes you to a PMDA table that shows the correction between ISO 13485:2003 and chapter 2 of ordinance 169.
Revision of Japanese Medical Device QMS requirements | Pharmaceuticals and Medical Devices Agency
Have fun.

 

[Ajit Basrur]

Sue789, here is a link to the PMDA website. It has a couple of links, one of which takes you to a PMDA table that shows the correction between ISO 13485:2003 and chapter 2 of ordinance 169.
Have fun.

You missed the link

 

[fialor]

Thanks for spotting.

 

[Gavin0209]

you can see the attached for MHLW 169.

 

[JeantheBigone]

Just FYI, the first link posted by fialor appears to be more current than the one posted by Gavin 0209. An revision was made on 25 November 2014.