Over labelling in Japan

Nat Nur · May 18, 2023

Hi,
Appreciate if anyone could share their experience or provide an input on overlabelling practice of medical device in Japan please.
I know certain country authorities do not have restriction on this but what about in Japan?

Hoping to get some clarification on this!
Thank You.

EmiliaBedelia · May 19, 2023

IME, overlabeling is basically expected in Japan because there are specific Japanese requirements that are needed, including the registration number, agent info, etc. If you are a foreign manufacturer you are required to have an MAH/DMAH in country who would be responsible for QMS, labeling, reporting, etc, Your in country agent should be able to advise on what they will handle on your behalf.

Nat Nur · Jun 22, 2023

EmiliaBedelia said:
IME, overlabeling is basically expected in Japan because there are specific Japanese requirements that are needed, including the registration number, agent info, etc. If you are a foreign manufacturer you are required to have an MAH/DMAH in country who would be responsible for QMS, labeling, reporting, etc, Your in country agent should be able to advise on what they will handle on your behalf.

Thank you so much Emilia!

Over labelling in Japan

Nat Nur

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Nat Nur

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