Medical Device Software CFDA Registration

Since 2003, CFDA started to supervise and manage medical software as medical device. Medical device software supervision is getting stricter, as the development of the regulations. Based on this tendency, the medical device software manufacture need to apply for and obtain the Medical Device Registration Certificate for their medical device software product in China.

CIRS has unscrambled the registration procedure and data requirements for medical device software registration and how to deal with the CFDA supervision and management in China.
The guideline for technical review of medical device software registration was issued by CFDA in 2015. If you would like to get the EN version of this guideline, please complete this order form.

I. Classification
Medical device software includes software components and independent software. Software component is a part of the medical device. However, independent software itself works as medical device

For the software component, it is a part of the medical device. The management type for the software component is the same as medical device products. Until now, none of the medical device software classified as class I medical device software. If the product is not included in the classification catalogue, we should apply for the classification determination.

The steps of classification determination application

The required documents gathering and translation
Submit the application online via Medical device classification information system Click (CN:医疗器械分类界定信息系统)
Register & fill the form ‘Classification Determination Application’& upload other supporting documents
Print all the document you fill online
Put all the documents in the envelope and close with the company stamp
Send all the documents to CFDA Medical Device Standard Management Center
The CFDA issued the final classification decision for your product.

Application required documents (all the documents should be in Chinese version):

Classification determination application
Product pictures/product structure pictures
Product standard and program explanation(if can provide)
Overseas listing certificate
Other related dossiers

II. Registration examination
After determine the classification, the oversea companies can start the product examination. And it will take about two months.

What you need to provide for the registration examination?

Sample products
Products technology requirement
Products instructions
Products labels

*For some medical devices with software, the loading hardware (Ex: laptop, cell phone, platform and etc.) for the software not always in the medical devices. In this situation, companies should also provide the hardware for the examination.

For the independent software, companies should provide both the basic dossiers and filling the form ‘Medical Device Software Examination Acceptance Statement ’. In the statement, company should describe the module, function list, working principle, usage and etc. At the same time, the hardware working with the software should be tested together.

CIRS suggests examination centers for the general software examination

Beijing Medical Device Administration(CN:北京市医疗器械检测所)

Guan dong Medical Devices Quality Surveillance and Test Institute(CN:广东省医疗器械质量监督检验所)

Jiangsu Institute of Medical Device(CN:江苏省医疗器械检验所)

Tianjin Medical Device Quality Supervision and Testing Center(CN:天津医疗器械质量监督检验中心)

Shenyang Medical Device Quality Supervision and Testing Center(CN:沈阳医疗器械质量监督检验中心)

Zhejiang Institute of Medical Device Testing (CN:浙江医疗器械检验院)

Shanghai Testing & Inspection Institute for Medical Devices (CN: 上海医疗器械质量监督检验中心)

III. Clinical evaluation
The Class II and Class III Medical Devices with software components or independent software should do the clinical evaluation. Companies could follow the requirement of ‘Medical Device Clinical Evaluation Technical Guideline’. Based on the products’ situation, companies could choose the clinical evaluation methods:
1. Apply for clinical trials exemption
2. Use the data from the similar products
3. Conduct clinical trials
Software components should combine with the medical device to conduct the clinical evaluation. And companies have to submit the medical device clinical dossiers.
Independent software also have to do the clinical trials. If the independent software have some non-clinical function like print, data management we can check through the software test. We only conduct the clinical trials for the clinical function.

IV. Dossier Submission, technical review and CFDA administrative approval
Registration dossiers difference: software components products should provide a description document about the software. And according to ‘Medical Device Internet Security Audit guideline’, the products that connect to the internet have to submit a document about internet security description.

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