Document 1: Application Form	
Document 2: Letter of Authorization for Agent	
Document 3: List of Basic Requirements for Safety and Effectiveness of Medical Device	
Document 4: Overview	
Document 4.1 Executive Summary
Document 4.2 Device Description
Document 4.3 Catalogue/Model
Document 4.4 Package Description
Document 4.5 Indication and/or Intended Use and Contraindications
Document 4.6 Reference to Similar and Previous Generations of the Device (if have)
Document 4.7 Other description
Document 5 Research Documents
Document 5.1 Performance Study
Document 5.2 Biocompatibility Evaluation Study
Document 5.3 Biological Safety Study
Document 5.4 Sterilization and Disinfection Process Study
Document 5.5 Shelf Life and Package Study
Document 5.6 Animal Study
Document 5.7 Software Study
Document 5.8 Other Study
Document 6 Manufacturing Information
Document 6.1 Manufacturing Processes
Document 6.2 Design and Manufacturing Sites
Document 7 Clinical Evaluation	
Document 8 Risk Analysis	
Document 9 Product Specifications	
Document 10 Registration Test Report
Document 10.1 Test Report
Document 10.2 Pre-evaluation Comments
Document 11 Instructions for Use and Label	
Document 11.1 Instructions for Use
Document 11.2 Label of smallest trading unit
Document 12 Conformity Statement	

This article is writed by medical device registration department of Beijing Golden Certification International Technology service Co., Ltd.Just for your reference.Any questions please contact us.