Announcement On Record Filling Of Medical Device Master Files

Announcement on Record Filling of Medical Device Master Files
The record filling system of medical device master file is
established in order to implement the State Council’s Opinions on
Reforming the Drug and Medical Device Review and Approval System
([2015] No. 44), further improve the quality of medical device review
and approval, establish a more scientific and efficient review and
approval system, and protect business secret. The medical device
master file is a form of technical documentation. This type of
information is submitted by the owner to the medical device
technical review institution to authorize the applicant to use the
medical device registration, etc., but not directly disclosing the
content. The contents of master file may relate to medical device raw
materials (excluding in vitro diagnostic reagents) and so on. This
record filing is voluntary. The record filing receipt only proves that
the master file is to be archived for use in the medical device
registration, modification, clinical trial approval and etc. The relevant
matters are announced as follows:

1. The record filing of master files used by medical device
   applicants in the application for registration, modification, clinical
   trial approval, etc. of medical devices (including in vitro diagnostic
   reagents) shall apply to the requirements of this announcement.
2. From the date of publication of this announcement, the
   Center for Medical Device Evaluation of NMPA (hereinafter referred
   —2—啊
   to as CMDE) establishes a medical device master files record filing
   platform (hereinafter referred to as the record filing platform) and a
   database. The owner of master files may submit the master file
   record filing materials through the record filing platform in
   accordance with the requirements of this announcement, and the
   master file record filing number is obtained through formal
   examination. After the application for registration of the associated
   medical device is submitted, master files will be reviewed together.
   The owner of domestic master files can apply for record filing
   on its own. The owner of imported master files(including Hong Kong,
   Macao and Taiwan) may apply for record filing or entrust an agency
   to apply for record filing.
3. The master file record filing materials shall be signed by the
   owner of master files, including the basic information of the owner
   of master files, record filing items and etc. Simplified Chinese
   translations are also required for foreign language files.
4. After filling the basic information in the CMDE record filing
   platform, the owner of master files submits the record filing
   application form of medical device master files, the updated record
   filing application form of medical device master files (Appendices 1
   and 2), the supporting documents, the authorization documents, the
   technical materials and other record filing documents to the NMPA
   Acceptance Center (Address: Floor 1, Gate 3, Dacheng Square, No.
   —3—啊
   28, Xuanwumen West Street, Xicheng District, Beijing). The owner of
   master files is responsible for the authenticity of record filing
   information to claim the authenticity of the record filing information
   submitted. The administrative acceptance department shall conduct
   a formal review of the intended record filing materials within 5
   working days after receiving the dossiers. After the dossiers meet the
   requirements, the owner of master files or its agent will be provided
   with the record filing receipt of medical device master file (Appendix
   3), and NMPA will publicize the record filing information as
   appropriate.
5. The specific requirements for the record filing of medical
   device master files can be found in the “Guidelines for the Record
   filing of Medical Device Master Files”.
6. When the content of the recorded medical device master files
   changes, the owner of master files can apply for record filing update
   in time, and the application form for record filing update of medical
   device master files is shown in Appendix 2.
7. The format requirements for the record filing application of
   medical device master files are shown in Appendix 4.
   This announcement is implemented as of the date of
   promulgation.
   —4—啊
   Appendix:
8. Record filing application form of medical device master files
9. Updated record filing application form of medical device
   master files
10. Record filing receipt of medical device master files
11. Format requirements for record filing dossiers of medical
    device master files
12. Record filing information of medical device master files