Japanese Requirements for Medical Devices - JPAL Ordinance 169 + "law" references

R

regsrule

#1
Hi all,
I am trying to get my head around Japanese requirements for medical devices. I am working my way through JPAL Ordinance 169 Quality system requirements.

I have got to the part about "Responsible Engineering Manager" (Article 16).
Within this article it references a number of other articles, e.g.
"The top management shall ensure that the responsible engineering manager specified in Paragraph 5 of Article 17 of Law" and "Paragraph 1 of Article 13-3 of Law".

The problem I am having is I cannot find the articles referenced. It doesn't appear to be referencing article 17 of Ordinance 169 so which document is it referring to?

If someone could set me straight it would be very much appreciated!!!

Thanks in advance :bigwave:
 
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Ajit Basrur

Staff member
Admin
#2
Welcome to the Cove, regsrule :bigwave:

Did you check the "Mutatis Mutandis" on pages 44 and 45 - there is a mention of the change to be done for Engineering Manager as -

“responsible engineering manager specified in Paragraph 5 of Article 17 of Law” in Article 16 shall read “drug manufacturing manager specified in Paragraph 3 of Article 17 of Law"

But there is only one paragraph for Article 17 ... so am unable to figure out if its a typo error !

Does anyone have any idea on this ?
 
R

regsrule

#3
Thanks for your input Ajit.
It feels to me like it is referring to a different document.

I'm also trying to understand the 'technical file' requirements for medical devices. I think they have adopted the STED format. And I have come across references to the 'Essential Principals':

MHLW notice No. 122/2005 ?

Essential requirements for Medical Devices

But this seems to be impossible to find anywhere. Perhaps it hasn't been translated? :mg:

If anybody has any pearls of wisdom they would be very much appreciated!

Thanks.
 
C

CBAL08

#6
Which is the latest Version of MHLW Ministerial Ordinance No. 169? Can anyone help out With this.
 
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