Operation Specification For Record Filing Of Medical Device Master Files

Operation Specification for Record Filing of
Medical Device Master Files
Article 1 In order to clarify the specific requirements for
the record filling application, update and transfer of medical
device master files (hereinafter referred to as master files), this
specification is prepared in accordance with the “Administrative
Measures for the Registration of Medical Devices” and the
“Administrative Measures for the Registration of IVD Reagents”
as well as the actual situation of the Center.
Article 2 Master files are divided into the master files and
the updated master files. The master files default to the first
submitted master files. The updated master files refer to the
master files updated by the owner of master files or its agency.
The updated master files shall include a change comparison
table and the updated master files.
The owner of master files or its agency shall provide the
record filing and update history list of master files when
submitting the master files. The list shall indicate the master files
record filing No. and acceptance time of the previous record
filing and update.