Document retention Policy for Japan's PMDA

bill.Kal

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hi Medtech Community,
Who can help me retrieve the following in info?
  1. What is the document retention policy when submitting documentation to launch a medical device in Japan?
  2. Is there a difference for clinical investigations?
Thank you for your help!
 

ECHO

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What is the document retention policy when submitting documentation to launch a medical device in Japan?

I believe they follow ISO 13485.
Here is an article about record retention for ISO 13485:
ISO 13485 Quality Record Retention Period

Is there a difference for clinical investigations?
I assumed you mean compared to FDA. Short answer is yes. Long answer is it really depends on your product.
Try this first. https://www.pmda.go.jp/files/000153732.pdf
 
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