Medical Device

For normal medical devices, a total of 12 basic documents must be collected and submitted to the SFDA. Documents must be in both Chinese and original language or English:

• SFDA registration application form
• Legal Production Qualification
• Authorization of Registration Agent in China
• Marketing approval from original government or CE/FDA
• Quality Guarantee Letter
• Authorization Letter to a Chinese Legal Agent
• Authorization Letter for After Sales Service in China
• Self-guarantee Declaration Letter
• Chinese Product Standard
• Package Insert / Product Label
• Clinical Trial Report or article
• SFDA Testing Report
• Testing report issued by SFDA certified testing center (if applicable).

IVD reagent

For IVD reagents, the following documents must be collected and submitted to the SFDA. Documents must be in both Chinese and original language or English:

• SFDA registration application form
• Legal Certification
• Research Summary
• Product Insert
• Product quality specification
• Testing report
• Research information of key raw materials
• Research information on manufacturing process or reaction system
• Analytical performance evaluation data
• Reference value (reference range) determination data
• Stability data
• Clinical research data
• Production records and QC release report
• Product package and label artwork
• Quality management system inspection report
• Legal Production Qualification
• Authorization on Registration in China
• Marketing Approval from Foreign Government
• Quality Management System Certification 
• Quality Guarantee Letter 
• Authorization Letter to a Chinese Agent 
• Self-guarantee Declaration Letter