The submission structure of registration application
Regional Administrative
Submission Table of Contents
List of Terms/Acronyms
Application Form
Listing of Device(s)
Quality Management System, Full Quality System or Other Certificates
Pre-Submission Correspondence and Previous Regulator Interactions
Statements/Certifications/Declarations of Conformity
Letters of Reference for Master Files
Other Regional Administrative Information
Submission Context
Chapter Table of Contents
General Summary of Submission
Device Description
Indications for Use and/or Intended Use and Contraindications
Global Market History
Other Submission Context Information
Non-Clinical Evidence
Chapter Table of Contents
Risk Management
Essential Principles (EP) Checklist
Standards
Non-clinical Studies
Non-clinical Bibliography
Expiration Period and Package Validation
Other non-clinical Evidence
Clinical Evidence
Chapter Table of Contents
Overall Clinical Evidence Summary
IRB Approved Informed Consent Forms
Other Clinical Evidence
Labelling and Promotional Material
Chapter Table of Contents
Product/Package Labels
Package Insert/Instructions for Use
Physician Labelling
Patient Labelling
Technical/Operators Manual
Other Labelling and Promotional Material
Quality Management System Device Program
Chapter Table of Contents
Regulatory information
TIPS
Agent: The representative office established by the overseas manufacturing enterprises that exports medical device to China or the designated enterprise legal person in China is called an agent.
Registered agent: Registered agent refers to the service organization that helps the applicant/registrant to handle registration related matters, and has no necessary connection with the agent.
In general, there is only one agent and there can be more than one registered agent.
