Medical Devices
No.
Title
Date
1
Principles of Drafting Chinese/English Product Names and Application Form
2022-07-07
2
Principles of Preparing Labels and Instructions
3
Medical Device Business Permit
4
Original Copy of Manufacture and Free Sale Certificates of the Country of Origin
5
Original of the foreign original manufacturer authorization letter
6
Document verifying that medical device manufacturer conforms to the Medical Device Quality Management System Regulations
7
Test specifications and methods of preclinical testing and quality control conducted by the original manufacturer, the original test records, and the test reports
8
Documents relating to product structures, materials, specifications, functions, intended uses, and drawings
9
Clinical evidence information
10
Radiation safety information for equipment generating ionizing radiation