Medical Device and Pharmaceutical/Drug Master File (MF) Submission in Japan

Japan has a Master File (MF) system for drug substances which allows Japanese or foreign manufacturers to voluntarily register their data concerning the quality/manufacturing methods of their products directly to the review authority. Drug MF submission allows for protection of intellectual property. The type of information that can be registered in a drug/pharmaceutical MF include manufacturing methods, manufacturing process control, specifications and test methods, information on safety, etc.

The Device Master File, otherwise known as "Seihin Hyojun Sho," is different in concept from a drug master file. It is a required document clarifying the specifications and Quality Management System as applied to the requirements of an individual product. Its contents parallel many ISO requirements.

PBM can help assemble these medical device and drug/pharmaceutical files to submit to the Japan Pharmaceuticals and Medical Devices Agency (PMDA).

For more information on product registration in Japan, please see the following PBM publications and/or contact us to discuss your specific needs.

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