Reporting Times & Requirements for when an Adverse Event has occurred (Japan)

R

regsrule

Hi all.
Could anybody help me with the reporting times / requirements for when an adverse event has occurred with a medical device in Japan.

There are a couple of IMDRF/GHTF documents that might help me... but the fact that there are more than one, with different information in doesnt help!

 GHTF SG2 - Medical Device Postmarket Vigilance and Surveillance - Timing of Adverse Event Reports - 27 September 2002 and[FONT=&quot]Medical Devices[/FONT][FONT=&quot] Post Market Surveillance:[/FONT][FONT=&quot]Global Guidance for Adverse Event Reporting for Medical Devices (2006)[/FONT]:

Serious injury or public health threat (including death) - immediately
Other events - 30 days.

Or if I look at Comparison of the Device Adverse Reporting Systems in
USA, Europe, Canada, Australia & Japan (2002)

Then there are a number of different reporting times based on whether or not it was off label use:
? Unlabeled serious incidents or near incidents ? 15 days
? Labeled serious incidents or near incidents ? 30 days
? Unlabeled medium level incidents or near incidence ? 30 days
Serious incidents by infectious diseases that could be caused by using medical devices ? 15 days.

What is correct? What do you all work to?

Thanks in advance for your guidance! :thanx:
 
Last edited by a moderator:
D

Doug Tropf

Quite Involved in Discussions
Have a look at the attached.
 

Attachments

  • Article 253 reporting adverse reactions.pdf
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C

cplpro18

off topic: hey everybody, i'm new here :) I'm a medical engineering Student and working on my bachelor Thesis about the vigilance process at a german Company

back to topic: @Doug Tropf, I think it's from "The Pharmaceutical Affairs Law. Enforcement Ordinance and Enfocement Regulation 2005/07"This book is out of order :( do you have this book? It would be gorgeous to get a copy/scan/photo of the pages to adverse event reporting and recall. The hole requirements to act if an adverse event in Japan happen.

Greetz Benedikt
 
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