IVD device distribution, what to do?

Paperman

Starting to get Involved
#1
Question 1:
Our company designs and manufactures reagents and software for tissue typing. I am investigating the requirements to distribute these products in Japan as in-vitro diagnostic (IVD) for diagnostic purposes.
According to information the medical device regulatory approval process starts with: "Determine classification of your device according to the Japanese Pharmaceutical Affairs Law (PAL)and Japanese Medical Device Nomenclature (JMDN) codes."
So far I have not been able to find current English versions of the PAL, and three appendices with JMDN codes I found through Elsmar Cove posted link [http://www.std.pmda.go.jp/stdDB/index_e.html] only mention equipment, not IVDs.
Current situation is that I don't know which procedure to follow, class I, II, III or IV.
Isn't there more straight forward Japanese regulatory documentation like the European IVD-directive or the Canadian MDR?

Question 2:
Our Japanes distributor claims that it is permitted to sell CE-IVD products not registered in Japan as RUO in Japan. Is this true? It seems unlikely to me after all the label carries the IVD symbol as specified in (EN)-ISO 15223-1:2012,IDT.

Thank you in advance for your assistance.
 
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T

TroutBrook

#2
Hi Paperman,

My own personal experience:

a) Finding JMDN codes can be difficult for IVDs. I spent a lot of time googling and using google translate to cipher something out. I searched competitor products (some were selling RUO) and ultimately didn't find anything useful. You may have to approach the authority or consultant for some help.

b) Japan can surprise you with how they perceive and classify devices. For example, two different (and very reputable) consulting companies independently came to the determination that our IVD controls were not considered IVDs in Japan and couldn't be cleared independently without all components of an assay. I found that odd based on how they've been regulated in other markets but I think it's reflective of IVD regulatory in Japan overall...it's just different. We ended up going forward with IVD symbols removed from labeling and never had an issue (although who knows what may happen during first MDSAP audit).

TroutBrook
 
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