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Determination of regulatory requirements for a marketing authorization of a medical device to be newly introduced into the Japanese medical device market.
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Development of strategy and planning for a regulatory submission.
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Advisory services for the development of QMS to be consistent with the Japanese GMP requirements( based on ISO13485:2003)
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Registration of a foreign manufacturing establishment prior to the submission of an application for a marketing authorization
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Japanese translation of application related documents ( QMS quality manual, attachment data etc)
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Selection of a third party certification body for a designated Class II type medical device to be submitted for marketing authorization.
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Identification of a marketing authorization holder (MAH) for a regulatory submission (either in the name of MAH or on behalf of a foreign medical device manufacturer).
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Support for the preparation of an application dossier and submission to a third party certification body for a designated Class II medical device.
- Preparation of application documents based on the essential principles.
- Preparation of application documents based on the applicable technical assessment standards
(JIS standards).
- Preparation of application documents related to the GMP standards.
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Support for preparation of answers to questions from the selected third party certification body after the submission.
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Consulting services on regulatory submissions to PMDA for non-designated Class II, Class III and Class IV medical devices.
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Electronic submission of an application dossier to PMDA for a marketing authorization.
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Applications for obtaining a business license for MAH and retail business
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Support for the development of GVP and GQP systems required by MAH
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