1. 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

 
 
2. 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 agentrefers to theservice 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.