R
regsrule
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
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