Declaration of information first level title

Declaration of information secondary title

1. Application Form

Application Form for Overseas Registration

2. Proof of document

Certificate of approval or approval of the product as a medical device to enter the country (region) market; certificate of qualification of medical equipment manufacturing enterprise

3. List of Safe and Effective Basic Requirements for Medical Devices

4.  Summary information

4.1 Overview

4.2 Product Description

4.3 Model specifications

4.4 Packing instructions

4.5 Scope of application and contraindications

4.6 reference to the same product or the previous generation of the product (if any)

4.7 Other explanations

5.  Research material

5.1 Product performance research

5.2 Biocompatibility Evaluation Study

5.3 Biosafety Research

5.4 sterilization and disinfection technology research

5.5 Validity and Packaging Research

5.6 Animal studies

5.7 Software Research

5.8 other

6.  Manufacturing information

6.1 Passive product / active product production process information description

6.2 Production site

7.  Clinical evaluation data

8.  Product risk analysis data

9.  Product technical requirements

10.  Product registration inspection report

10.1 Registration inspection report

10.2 Pre-evaluation comments

11.  Brochures and label samples

11.1 manual

11.2 The label of the minimum sales unit

12. DOC