Japanese medical device recall requirements & procedure for foreign manufacturers

#1
Dear forum,

I am trying to find out how medical devices are recalled in Japan for a European manufacturer.

Could someone please post the procedure or a link?

Best regards,
Delvyn
 
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JoshuaFroud

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#3
Dear forum,

I am trying to find out how medical devices are recalled in Japan for a European manufacturer.

Could someone please post the procedure or a link?

Best regards,
Delvyn
Good Morning, and welcome.

Do you have an authorised representative within the country? I would suggest they be your first port of call for this kind of information. If that is not an option, I would suggest contacting the PMDA directly PMDA Website. Usually, the appropriate regulatory agency within a country is more than willing to provide assistance when there is a safety concern for a device. I have no direct experience with Japan myself but having had a look around in the normal places I was not able to locate much to help you apart from the suggestions above.
 
#4
Good Morning, and welcome.

Do you have an authorised representative within the country? I would suggest they be your first port of call for this kind of information. If that is not an option, I would suggest contacting the PMDA directly PMDA Website. Usually, the appropriate regulatory agency within a country is more than willing to provide assistance when there is a safety concern for a device. I have no direct experience with Japan myself but having had a look around in the normal places I was not able to locate much to help you apart from the suggestions above.
Thank you Joshua!
 
#5
You have either a Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (DMAH), if you have a MAH, you need to work through them as they are responsible for you and post-market surveillance activities. If you have a DMAH, they will still be your first point of contact but it will cost you to have them assist with the recall.
 
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