E
esh14
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.
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.
