Medical Devices
CIRS Group
Chemicals
Cosmetic
Food
Medical Devices
Agrochemicals
C&K Testing
Carbon Neutrality
Search

Technical Files Compilation

According to the appendix of the "Announcement of Medical Device Registration Application Document Requirements and Approval Document Format (2014 No. 43)", the following materials are required for the registration application of medical devices: 

Item

Description

1. Application form

 

2. Supporting documents

2.1 Copy of original registration certificate

2.2 Copy of business license

2.3 Copy of manufacturing certificate

2.4 Copy of report released by the third institute (if any)

3. List of basic requirements for safety and effectiveness of medical device

 

4. Summary

4.1 Overview

4.2 Product description

4.3 Model and specification

4.4 Packing instructions

4.5 Applicable scope and contraindications

4.6 Referenced clinical data of products of same kind or its predecessors (if any)

4.7 Other contents to be specified

5. Research Information

5.1 Product performance study

5.2 Evaluation study on biocompatibility (if any)

5.3 Biological safety study (if any)

5.4 Sterilization / disinfection process study (if any)

5.5 Study on shelf life and packaging

5.6 Animal study (if any)

5.7 Software study (if any)

5.8 Others

6. Manufacturing information

6.1 Enterprise introduction: including the staff number, manufacturing site, etc.

6.2 Checklist of manufacturing facilities & equipment

6.3 Checklist of testing facilities & equipment

6.4 Process flow diagram (PDF): including the key process & process

7. Clinical evaluation material

 

8. Risk analysis material

 

9. Product technical requirement

9.1 Product standards

9.2 Corresponding testing methods

10.Product testing report

10.1 Type-testing report

10.2 Pre-assessment advice on Product technical requirement

11. Instruction manual and label

11.1 Instruction for use

11.2 Label samples of minimum sales uni

12. Statement of conformity

 


With rich registration experience, CIRS can assist in the preparation of required technical files for medical device registration according to the needs of enterprises. 

Contact Us
+86 571 8720 6559 (EN)
Contact Us
+86 571 8720 6559 (EN)