How to Compile Medical Device Software Registration Application Dossiers. - Regulatory News - Medical Devices

October 1^st 2014, CFDA issued the announcement about medical device registration application dossiers requirement and approved certificate format（CFDA 43th statute）. CIRS summarized the main points in the chart below.

Medical device registration application dossiers Chart

Application dossier (headline)	Application dossier (subtitle)
1.Application form
2.Certification
3.Medical device safety and efficiency requirement list
4.Summarizing documents	4.1 Summary 4.2 Product description 4.3 Model 4.4 Packaging instructions 4.5 Applicable area and contraindication 4.6 Reference related products or old generation products(if any) 4.7 Other supporting content
5. Research documents	5.1 Product property research 5.2 Product compatibility evaluation research 5.3 Biology safety research 5.4 Sterilization and disinfection study 5.5 Expiration date and packaging research 5.6 Animal study 5.7 Software research 5.8 Others
6.Products manufacturing information	6.1 Passive products/active products manufacturing process information description. 6.2 Manufacturing location
7.Clinical evaluation documents
8. Products risk analysis documents
9. Products technology Requirements
10. Products registration examination report	10.1 Registration examination report 10.2 Pre-assessment
11. Instructions and label sample	11.1 Instructions 11.2 The smallest product label sample
12. Compliance statement

All the points listed in the chart above are required for the medical device and medical device software CFDA registration, but medical device software need to focus more on the point 5.7 software research.
August 5^th 2015, CFDA issued ‘Medical Device Software Registration Audit Guide Principle’. It is a guide about medical device software registration dossiers submission from the manufacturing companies. Also it can standardize medical device software technical audit requirement. And in this principle, the main contents include the range, basic principle, software describing document, software updating, software version, ready-made software, registration dossiers and etc.
On January 24^th 2017, CFDA drafted ‘Medical Device Network Safety Registration technology Audit Guideline’ in addition. This guideline is good for the medical device products that connect with the internet for the data exchange or remote control to submit registration application. And this guideline will be enforced on January 1^st 2018. Since then, the registrants need to submit a network safety describing document. At the same time, registrants have to clarify the data interface and user access control in the product technical requirements documents. And in the product instruction, it should clearly point out network safety requirement.

Related links about medical device software registration

Medical Device Software CFDA Registration
Medical Device Software Version Monitoring and Case Study
How to Compile Medical Device Software Describing Documents for CFDA Registration (with the sample document created by CIRS)

*If you have any questions, feel free to contact CIRS at md@cirs-group.com

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