Regulatory Open Forum

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  • 1.  Adverse Event Reporting

    Posted 30-Jan-2012 07:38

    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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  • 2.  RE:Adverse Event Reporting

    Posted 30-Jan-2012 09:19
    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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  • 3.  RE:Adverse Event Reporting

    Posted 30-Jan-2012 10:19
      |   view attached
    Gary,

    The attached pdf file may be of help to you.  The GVP requirements are the responsibility of the MAH; I am unaware of any link to the requirements translated to English.



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    John Beasley RAC
    Founder and Senior Consultant
    Medtech Review, LLC
    Minnetonka MN
    United States
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    Attachment(s)



  • 4.  RE:Adverse Event Reporting

    Posted 30-Jan-2012 10:24
    Gary,

    You can also purchase "Fundamentals of Japanese Regulatory Affairs, 1st Edition" from RAPS.  Chapter 12 contains all information on GVP requirements which you may be looking for.

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    John Beasley RAC
    Founder and Senior Consultant
    Medtech Review, LLC
    Minnetonka MN
    United States
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  • 5.  RE:Adverse Event Reporting

    Posted 30-Jan-2012 22:55
    Hi,
    Adverse Event reporting in Japan:
    A procedure must exist which describes the notification process to the MAH regarding adverse events.  This process must include the following:the following must be reported within 15 days:
    -Death
    -Impediment
    -Case which has the possibility of death or Impediment
    -Hospital admission (for curing or extension of admission period)
    -Congenital diseases
    -The following must be reported within 30 days:
    -Cases that could attribute to the effect of a malfunction on the device
    -Cases of infection that could attribute to the cause of the malfunction
    -Cases where the user could not predict the malfunction based on the product labeling
    Regards,

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    Sattu Sreenu Babu RAC
    Life Technologies
    Singapore
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