Technical Files Compilation - Medical Device Filing/Recording and Registration - Medical Devices

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.