Q
Hi there,
I am wondering if anyone can help mit with the japanese PAL.
As a medical device manufacturer we have to go conform with the japanese PAL as we sell products to Japan.
I already have found several ordinances (such as number 169, number 2, number 136) describing the quality management system requirements to find out the differences to the ISO 13485.
But I cannot find any document describing the PAL.
Can anyone give me a hint where I can download it?
Does anyone know anything about the "essential principle checklist"?
for your help.
I am wondering if anyone can help mit with the japanese PAL.
As a medical device manufacturer we have to go conform with the japanese PAL as we sell products to Japan.
I already have found several ordinances (such as number 169, number 2, number 136) describing the quality management system requirements to find out the differences to the ISO 13485.
But I cannot find any document describing the PAL.
Can anyone give me a hint where I can download it?
Does anyone know anything about the "essential principle checklist"?
for your help.