Hello Gary,
Here is some information that you can find useful and hopefully answer your questions.
1. Unfortunately, I do not have a copy of the Post Market Safety Assurance requirements MHLW Ordinance #135 that describes this information; currently only in Japanese:
http://www.emergogroup.com/files/japan-mhlw-ordinance-135-japanese.pdf. You can probably put that document in Google translate to give you some good context; we are working on translating some of these documents internally. The summary is basically there is a Medical Device Reporting requirement for Japan like many other regulatory markets. You must register customer complaints, evaluate for MDR or Malfunctions, and notify Japan as required. Reports must be made to the Ministry @ 15 days for death/serious injury and @ 30 days for malfunction. There are some standard templates floating around for reporting, but if you utilize the same reporting template for other markets this should be adequate. You can find additional information about Japan here
http://www.emergogroup.com/resources/regulations-japan. 2. You probably did in fact read or hear about this somewhere. There is no specific guidance or requirement on device malfunctions that are specifically related to prolonged surgical procedure requiring FDA notification through the Medical Device Reporting (MDR) system. The only place that I can point you is 21 CFR 803 and the FDA website that defines a malfunction with some examples that they provide
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. I recommend to organizations that if there is any doubt about filing, sometimes it is better safe than sorry. The key with reporting or not reporting MDRs is that if you decide
not to report an MDR,
document the rationale, decision, justification for not reporting. We also advise that companies review their Risk Management File to make sure that hazard has been clearly identified and is an acceptable risk for the medical device.
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Richard Vincins RAC
Vice President, QA
Emergo Group Inc
Austin TX
United States
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Original Message:
Sent: 01-30-2012 07:37
From: Gary Syring
Subject: Adverse Event Reporting
1. Does anyone know of an internet link for the Japan Ministry of Health, Medical Device Adverse Event Reporting requirements, in English?
2. I remember reading or hearing advice if a medical device malfunctions and prolongs a surgical procedure, the device malfunction is reportable to FDA as a Medical Device Report. I have not found this documented in any FDA guidance. Any references or guidance?
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Gary Syring
Prin Consultant
Quality & Regulatory Associates LLC
Stoughton WI
United States
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