Sue789

Involved In Discussions
#1
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
 
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fialor

Involved In Discussions
#2
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.
 
Last edited:

JeantheBigone

Quite Involved in Discussions
#6
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.
 

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