Guideline For Record Filing Of Medical Device Master Files

I. Definition and purpose
The medical device master files is a form of technical
documentation. This type of materials is submitted by the owner to
the medical device technical review institution, in order to authorize
the applicant for use in the medical device registration, etc., but does
not directly disclose the content. This guidance is intended to guide
the owner of master files in the record filing and authorization of
medical device master files.
II. Regulatory basis
Administrative Measures for Medical Device Registration
Administrative Measures for IVD Reagent Registration
Medical Device Registration Application Requirements and
Approval Document Format
IVD Reagent Registration Application Requirements and
Approval Document Format
III. Applicable scope
This guidance applies to the mater files used by applicants in
applications for registration, modification and clinical trial approval
of medical devices (including in vitro diagnostic reagents). The
master files are submitted directly to the medical device technical
review institution by the owner of master files, due to technical
secrets or avoiding repeated submission of the same document.
IV. Basic principle