Japan Master Files for Device materials?

Hi all,
Does anyone know the status of a device materials master file system in Japan? I know they have drug master file system and I found information from recent years (exact date unknown) that indicates a device materials system was under review- thanks!

A quick 'Bump'. Can anyone help with this one? My Thanks in advance!

I'm not sure if this answers your question but the JQMS at article 6, paragraph 2, does require what is termed a Product Master File. This file is to contain information which is included in the Device Master Record and the Design History File.

AnaMariaVR2 said:

It is bit unclear your question. Are you talking about the whole process? How to file for one in Japan? Or how to track the status of one already submitted in Japan?

Here are some files that might be useful.

Good luck,
~Ana

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Thank you! Sorry for not being clear. You are on the right track - the files that you provided are for DRUG master files (and are helpful!) but I was wondering if there was a similar MF process for medical device MATERIALS. I have a client who is a raw material supplier and they would like to utilize a master file -

tehuff said:

Thank you! Sorry for not being clear. You are on the right track - the files that you provided are for DRUG master files (and are helpful!) but I was wondering if there was a similar MF process for medical device MATERIALS. I have a client who is a raw material supplier and they would like to utilize a master file -

Click to expand...

Hello everybody!

Does someone know anything about the content of Seihin Hyojun Sho (Japanese Device Master Record) for a medical device class II (Japanese classification)?

Or can you provide a draft?

Thank you very much