Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

I recently learned that our company is shipping medical devices to Japan without having any documentation on who the Marketing Authorization Holer (MAH) is. I tried looking into a recent order and it is going to an end user rather than a distribution facility, a bit unexpected because it is a small medical practice and I didn't think such an office could become a MAH. We asked the customer to provide evidence of registration and I received a certificate in Japanese and a 5 digit license number. They are unable to provide anything else in English. Can anyone apply to become a MAH in Japan? How can I know that the license number they provided is legitimate, is it always a 5 digit number for instance? Does anyone have any other insight or feedback on how to go about verifying their information? 

Thank you

Check there if you know when the product is approved:
https://www.pmda.go.jp/english/review-services/reviews/approved-information/devices/0001.html

In my expierence licence number is16 digits.

Contact some japanese firms, they have the access of registration data base in PMDA. And it handles also the exchange of old MAH which is complex.



Original Message:
Sent: 30-Jun-2020 10:15
From: Anonymous Member
Subject: Marketing Authorization Holder Japan

This message was posted by a user wishing to remain anonymous

Hello,

I recently learned that our company is shipping medical devices to Japan without having any documentation on who the Marketing Authorization Holer (MAH) is. I tried looking into a recent order and it is going to an end user rather than a distribution facility, a bit unexpected because it is a small medical practice and I didn't think such an office could become a MAH. We asked the customer to provide evidence of registration and I received a certificate in Japanese and a 5 digit license number. They are unable to provide anything else in English. Can anyone apply to become a MAH in Japan? How can I know that the license number they provided is legitimate, is it always a 5 digit number for instance? Does anyone have any other insight or feedback on how to go about verifying their information?

Thank you

Original Message:
Sent: 7/1/2020 7:44:00 AM
From: Antonio Lee
Subject: RE: Marketing Authorization Holder Japan

Check there if you know when the product is approved:
https://www.pmda.go.jp/english/review-services/reviews/approved-information/devices/0001.html

In my expierence licence number is16 digits.

Contact some japanese firms, they have the access of registration data base in PMDA. And it handles also the exchange of old MAH which is complex.



Original Message:
Sent: 30-Jun-2020 10:15
From: Anonymous Member
Subject: Marketing Authorization Holder Japan

This message was posted by a user wishing to remain anonymous

Hello,

I recently learned that our company is shipping medical devices to Japan without having any documentation on who the Marketing Authorization Holer (MAH) is. I tried looking into a recent order and it is going to an end user rather than a distribution facility, a bit unexpected because it is a small medical practice and I didn't think such an office could become a MAH. We asked the customer to provide evidence of registration and I received a certificate in Japanese and a 5 digit license number. They are unable to provide anything else in English. Can anyone apply to become a MAH in Japan? How can I know that the license number they provided is legitimate, is it always a 5 digit number for instance? Does anyone have any other insight or feedback on how to go about verifying their information?

Thank you