Reporting Medical Incidents in Japan
- Thread starter Dave-h
- Start date
Good afternoon,
Does anyone know who it is in Japan, that you would report medical device incidents or recalls etc to?
Ideally, I would like to find a website of the appropriate body.
Thanks for your help,
Dave
Can someone help Dave?
Thank you.
Stijloor.
T
teomanalpay
on emergogroups' website there is a collection of many countries' health regulations. japan is included.
Dear teomanalpay,
Thank you for your reply.
Emergogroups do indeed give lots of information about how they can help with regulatory compliance, and their "Learning" section reproduces many of the Japanese regulations, although I can't find an answer to this particular question. So I'm still looking....
Kind regards,
Dave
Thank you for your reply.
Emergogroups do indeed give lots of information about how they can help with regulatory compliance, and their "Learning" section reproduces many of the Japanese regulations, although I can't find an answer to this particular question. So I'm still looking....
Kind regards,
Dave
M
MIREGMGR
Your original post yesterday caused me to realize upon review that I was incorrect in thinking that I had this information...which of course was a major system flaw, since my company markets in Japan.
This information is surprisingly difficult to track down if you don't speak or read Japanese.
The key webpage, I think, is http://www.pmda.go.jp/english/service/regulations.html. This of course is in Japanese, and machine translations of Japanese are not very good. I'm still unclear on exactly where such reports go, even with the instructions. It seems almost as if paper filings go to the PMDA on behalf of the MOH, but electronic filings go to MHLW.
In any case, I think it's clear that all such filings must be in Japanese only, which means that the filing-preparation individual can sort out the requirements from the provided site.
This information is surprisingly difficult to track down if you don't speak or read Japanese.
The key webpage, I think, is http://www.pmda.go.jp/english/service/regulations.html. This of course is in Japanese, and machine translations of Japanese are not very good. I'm still unclear on exactly where such reports go, even with the instructions. It seems almost as if paper filings go to the PMDA on behalf of the MOH, but electronic filings go to MHLW.
In any case, I think it's clear that all such filings must be in Japanese only, which means that the filing-preparation individual can sort out the requirements from the provided site.
M
MIREGMGR
Heh. And from prior threads, even better information...read down the page, it's pharma at the top but devices info follows:
http://www.info.pmda.go.jp/mdevices/md2005-0317006.html
(This is from http://elsmar.com/Forums/showpost.php?p=375371&postcount=7 and http://elsmar.com/Forums/showpost.php?p=375371&postcount=9 .)
http://www.info.pmda.go.jp/mdevices/md2005-0317006.html
(This is from http://elsmar.com/Forums/showpost.php?p=375371&postcount=7 and http://elsmar.com/Forums/showpost.php?p=375371&postcount=9 .)
Dear Miregmgr,
Thank you for your replies. It is quite surprising how difficult it is to find this information.
Like you, I found the first web page that you mentioned, but as you say, it is not clear about where they would like the information to be sent.
I have sent an email to the PMDA asking for the reporting contact details etc. I'll let you know if they respond with something useful.
Thanks,
Dave
Thank you for your replies. It is quite surprising how difficult it is to find this information.
Like you, I found the first web page that you mentioned, but as you say, it is not clear about where they would like the information to be sent.
I have sent an email to the PMDA asking for the reporting contact details etc. I'll let you know if they respond with something useful.
Thanks,
Dave
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