Reporting Medical Incidents in Japan

Dave-h

Involved In Discussions
#1
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 :cool:
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
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 :cool:
Can someone help Dave?

Thank you.

Stijloor.
 

Dave-h

Involved In Discussions
#4
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
 
M

MIREGMGR

#5
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.
 

Dave-h

Involved In Discussions
#7
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
 
Thread starter Similar threads Forum Replies Date
Q When to File an MDR (Medical Device Reporting) For Incidents in Foreign Countries 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A Medical device Reporting : Good Faith Effort for Additional information Other US Medical Device Regulations 2
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
M Informational New Zealand – Changes to Medical Device Adverse Event Reporting process Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Medical device incident reporting (MDIR) guide Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Statement on agency’s efforts to increase transparency in medical device reporting Medical Device and FDA Regulations and Standards News 0
A Japan's Requirements for Reporting Medical Device Adverse Events Other Medical Device Regulations World-Wide 2
M Informational TGA – Medical device annual reporting – Sponsor obligations Medical Device and FDA Regulations and Standards News 0
shimonv Reporting Medical Device Changes with Annex V/VII EU Medical Device Regulations 1
L MDR (Medical Device Reporting) under 21 CFR Part 803 Other US Medical Device Regulations 5
Q Medical Device Reporting In US/ EU/ Canada Customer Complaints 6
N Notification of Changes to a Class I Medical Device - Reporting Requirements EU Medical Device Regulations 4
JoCam Incident Reporting MHRA (Medical & healthcare regulatory agency) EU Medical Device Regulations 3
S Medical Device Reporting SOP (Standard operating procedure) example Other Medical Device and Orthopedic Related Topics 1
A What are the obligatory medical device reporting timelines for AIMD devices ? ISO 13485:2016 - Medical Device Quality Management Systems 2
B Is there a MDR (Medical Device Reporting) equivalent in China ? China Medical Device Regulations 1
A 21 CFR Part 803 (Medical Device Reporting) and Public Health US Food and Drug Administration (FDA) 2
Q Reporting Significant Medical Device Changes to Argentina's ANMAT Other Medical Device Regulations World-Wide 3
S Help with EU Medical Device Vigilance Reporting Requirements EU Medical Device Regulations 0
M Weblinks in Medical Device Reporting Procedures ISO 13485:2016 - Medical Device Quality Management Systems 9
S FDA Warning Letter on Medical Device Reporting Interpretation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
R Role of Contract Manufacturer - MDRs (Medical Device Reporting) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
L Medical Device Reporting vs Recall/Correction: What action to take? US Food and Drug Administration (FDA) 5
S FDA terms - Adverse Events, Medical Device Reporting, MAUDE and Customer Complaints US Food and Drug Administration (FDA) 1
N Exclusion of Medical Device Reporting of Components for Medical Systems ISO 13485:2016 - Medical Device Quality Management Systems 4
T Reporting changes to a Class II Medical Device in Canada Canada Medical Device Regulations 3
G FDA MAUDE Medical Device Reporting Database Analytics US Food and Drug Administration (FDA) 6
D Malfunctions, 2 year History, and Medical Device Reporting 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
arios Flowchart to explain the Medical Device Vigilance Reporting Process wanted EU Medical Device Regulations 4
T EU Medical Device Vigilance Reporting Requirements EU Medical Device Regulations 3
S MDR (Medical Device Reporting) Justification - Canned Statements Other US Medical Device Regulations 2
T Medical Device Reporting Procedure ISO 13485:2016 - Medical Device Quality Management Systems 2
E Taiwan Medical Device Adverse Event Reporting Other Medical Device Regulations World-Wide 6
C Medical Device Reporting Procedures compliant with FDA and CE Marking Requirements EU Medical Device Regulations 7
T US FDA Medical Device Reporting SOP help 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
L Interpretation of MDR Reportable Event - FDA guidance on Medical Device Reporting 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
B Medical Device Vigilance Reporting Multi Markets Other ISO and International Standards and European Regulations 2
M Who regulates Medical Device? Global Medical Device Reporting Process Other Medical Device and Orthopedic Related Topics 6
bio_subbu OIG Reports on Medical Device Adverse Event Reporting system 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
C Medical Device Reporting procedure - Correction and Removal (21 CFR 806) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Draft Guidance: eMDR - Electronic Medical Device Reporting (Updated) US Food and Drug Administration (FDA) 3
O Medical Device Reporting - MDRs for incidences outside the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Canadian Medical Device Reg -- Mandatory Reporting? Various Other Specifications, Standards, and related Requirements 1
G ISO 17025-2017 Management Review reporting items - Inputs ISO 17025 related Discussions 1
F Risk for Quality Assurance Department in a Hospital - Hospital Incident Reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Differences in post market safety reporting for Combination Product Applicants Medical Device and FDA Regulations and Standards News 1
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
L Adverse Event Reporting New Zealand Other Medical Device Regulations World-Wide 11
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
MDD_QNA How to deal with FDA after not reporting anything for several years Other US Medical Device Regulations 14
Similar threads


















































Top Bottom