Record Filing Requirement Of Medical Device Master Files


I. Project Name: Application for record filing of medical
device master files
(i) Application form

  1. Check the integrity of application form;
  2. Confirm the consistency of the electronic information
    provided in the “Application Form for Record Filing of Medical
    Device Master Files”;
  3. The contents of master files may relate to medical
    device raw materials (except for in vitro diagnostic reagents).
    The master files of medical device raw materials may include
    raw material composition description, performance research
    data, biological evaluation data / toxicological risk analysis data
    and etc.
  4. Confirm the Chinese name, original name (if any) and
    specifications (if applicable) of record filing items;
  5. Quality standard refers to the source or execution basis
    of the standard submitted by this record filing application. If it
    comes from domestic standards, industry standards, the
    Pharmacopoeia of the People’s Republic of China, and the drug
    standards, it must be written in versions; if it is from the overseas
    pharmacopoeia, the name and version of the Pharmacopoeia
    shall be indicated; others refer to non-above sources, and shall
    write specific source, such as self-research.
  6. The owner of master files, the agency address, etc., shall
    be consistent with the relevant qualification documents such as
    the business license of the enterprise;
  7. The Chinese simplified characters shall be used to fill out
    the form, except for the necessary original texts.
  8. Overseas owner information of master files is
    recommended to be filled in Chinese and original text. If the
    original text cannot be identified, it can be filled in English.
  9. If the application form has attachment, the attachment
    shall be stamped with the official seal, attached to the
    application form, and the attachment content shall be uploaded
    in the record filing platform of medical device master files;
  10. The texts in the application form shall be concise,
    accurate, and not altered by handwriting;
  11. In the selective items, in addition to being clearly
    defined as a single selection, multiples may be selected or no
  12. The signature shall be autographed by the owner of
    master files or the relevant person in charge of the agency.
  13. The edge of each page of the printed application form
    shall be stamped with the official seal of the owner of master
    files or the agency.