Japan's MHLW #169 vs ISO 13485:2003

[RG Ohidy]

I have been looking for a cross reference table between Japans MHLW #169 and ISO 13485:2003.

Any suggestions on where to look for such a table, or if someone has one they would like to share?

Thanks,

Rich

 

[Marc]

What is the title of Japan's MHLW #169?

 

[Al Rosen]

What is the title of Japan's MHLW #169?

Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-vitro Diagnostic Reagents

BTW, MHLW = Minister of Health Labour and Welfare

Sorry, I don't have a cross reference, only an english translation that's posted in ISO13485:2003 vs. the Japanese PAL Ordinance No. 169 - Seeking Gap Analysis.

 

[RG Ohidy]

Ok, thanks, but I already have the 169, was just wondering if anyone had put a matrix together.
I'll see what I can do, and post one.

 

[Al Rosen]

Ok, thanks, but I already have the 169, was just wondering if anyone had put a matrix together.
I'll see what I can do, and post one.

Thanks!!

 

[RG Ohidy]

Here is a table I created. The table can be modified to include other standards/requirments, as well as listing procedures that apply to each.

Rich

 

[username]

Hi
That was a great work!
Do you happen to have an updated version of ISO 13485:2003 Vs. MHLW (Ministerial Ordinances on GQP & GMP) 2005?
Thanks
S

 

[Mary Flynn]

Thank you so much for this matrix, you have saved me a lot of time.

 

[Ajit Basrur]

Thank you so much for this matrix, you have saved me a lot of time.

Welcome Mary - it was good to note that the matrix was useful to you. Hope to see your active participation in the cove

 

[CBAL08]

Is the Matrix still valid after the changes as well which occured in November 2014?