Adverse Event Reporting in Japan

C

catal

Hi everybody

Does anyone know what needs to be reported to the MAH among incidents that occured outside Japan with product sold in Japan?

Thanks by advance for the answers!
 
Stijloor

Stijloor

Leader
Super Moderator
catal said:
Hi everybody

Does anyone know what needs to be reported to the MAH among incidents that occured outside Japan with product sold in Japan?

Thanks by advance for the answers!
Click to expand...

Can someone help?

Thanks!

Stijloor.
 
S

sreenu927

Quite Involved in Discussions
Attached is the guidance document from GHTF that includes what tobe reported and by when, etc..for Japan.

Hope this helps u!

Regards
Sreenu
 

Attachments

  • GHTF_Global AE Reporting_Guidance.pdf
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C

catal

Thanks for both links.
However I cannot make the first work
and I guess the second is not valid anymore since the GHTF report was edited in 2002 and the PAL modified the requirements in 2005. Am I right?
Thanks for helping
 
M

MIREGMGR

See this page for current GHTF documents pertaining to adverse event reporting. Document N6R3:2002, I believe, was at least two generations earlier than N54R8:2006. Study Group 2 includes representatives from Japan, and it's implied that the GHTF recommendations are consistent with all of the participating nations' requirements.
 
R

Reiko Shiratori

Hello catal,

I think this is what you are looking for, but written in Japanese:
http :// www .info.pmda.go.jp/mdevices/md2005-0317006.html - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

I tried to find out English information but I couldn't.

Please try a free website translator, or contact your Japanese marketing approval holder.

I hope this helps.

Reiko:)
 
Last edited by a moderator:
C

catal

Thank you all!
Yes Reiko Shiratori, I found that website and I think everything is there. I tried to translate it but I didn't find out clear regulation.

Do medical devices follow the reporting requirements of drugs and thus the same ordinance of the PAL?
If yes, I may find something this way
 
Y

yana prus

Hi,

Try to use the Google translator for the following page:

http :// www. info.pmda.go.jp/mdevices/md2005-0317006.html - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

there is quite clear explanation under "policy and reports / medical equipment"

Regards,

Yana
 
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