IVD Classification in Japan based on the Japanese Pharmaceutical Affairs Law



Hi everyone,

I would like to ask about the IVD classification system in Japan. I have read through a few sites and found out that the classification for IVD instrument and IVD reagent are categorized under two different systems (medical device & drug) based on the Japanese Pharmaceutical Affairs Law. The IVD instruments are classified under Class I medical devices.

However, after the implementation of the Japanese Pharmaceutical and Medical Device Act, the classification of the devices have been changed.

Thus, I want to know how is the classification system looks like for IVD reagent.

If possible please provide me some links for reference.

Thank you.


Quite Involved in Discussions
Hi Esh14,

I have attached the MHLW Ministerial Ordiance No.136,2004 for your reference


  • Japan-MHLW-Ord-136-QA-devices.pdf
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