How to register medical software in China?

“Software that has one or more medical purposes/uses, can complete its intended use without medical device hardware, and run on a general-purpose computing platform. The general computing platform meets the safety requirements of information technology equipment (including electromagnetic compatibility)”

This topic of SaMD is quite complex. We give some hint to register SaMD in China. So far the challenge to mark the SaMD in China is intransparent due to missing knowledge at authority, testing institutions and SaMD manufacturers und its usage at hospitals or at home. Still China remains an attractive market to enter earlier due to medical environment potential and huge populations which live already in artificial intelligence life.

1.    Determine classification of medical software

As at FDA there is a product code system in China which determines the product classification. All medical software belongs to 21-xx-xx main groups. So far there are only roughly 6 subgroups:

·        21-01 Treatment Planning Software

·        21-02 Image processing software

·        21-03 Data processing software

·        21-04 Decision Support Software

·        21-05 In vitro diagnostic software

·        21-06 Others

Including the last 2 digits among 6 product code there are 51 precise product code of medical device. For innovative SaMD which has no equivalent product to compare in China, there is a green pathway of registration with prerequisite that the medical device has a Chinese patent.

The first task for manufacturers is to match product code and classification depending on intended use of subject medical device.

2.    Create registration tactic

Regulatory requirements are following and guiding to which SaMD manufacturer should develop SaMD compliant. The technical dossier to submit is to adapt to Chinese regulation of software.

We list the most important regulations for SaMD below:

Regulation

• Guidance for Medical Device Software Registration Review, 2022
• Guidance for Medical Device Cybersecurity Registration Review, 2022
• Guidance for Registration and Review of Artificial Intelligence Medical Devices, 2022
• Guidance for Technical Review of Mobile Medical Device Registration, 2017

QM-related

• Guidance for On-Site Inspection of Independent Software of Good Manufacturing Practice for Medical Devices, 2020

Standard

• YY/T 0664-2020  Medical device software—Software life cycle processes

"As IEC 62304:2015"

• YY/T 1406.1-2016 Medical Device Software- Part1: Guidance on the application of ISO 14971 to medical device software

"As IEC/TR 80002-1:2009"   

• GB/T 25000.51-2016 Systems and software engineering—Systems and software Quality Requirements and Evaluation (SQuaRE)—Part 51：Requirements for quality of Ready to Use Software Product (RUSP) and instructions for testing

"As ISO/IEC 25051:2014"

• GB 4943.1-2011 Information technology equipment—Safety—Part 1: General requirements

"As IEC 60950-1:2005"

*Please refer to product specific standards as in guidance of Software Registration Review and Cybersecurity Registration Review as well in product specific guidance.

Belonging to registration plan are always the timeline of registration, resources plan (budget, personal) and competitor analysis.
 

3.    Make gap analysis of technical dossier

At the end of evaluation of registration of SaMD, a gap analysis is created to the current technical documentation of SaMD. Upon the gap the actions should be initiated in a project: prepare internal testing, type testing in China, draft IFU and perhaps Chinese interface language, plan of clinical evaluation or clinical study.

4.    Select a Chinese representative for registration

For foreign manufacturers you might need a Chinese representative (Chinse agent) to submit the dossier to NMPA if you don’t have a Chinese entity. However foreign manufacturers remain as marketing authorised holder in China which might be different than in Japan.

It could be nice to have a reliable Chinese distributor however not typical late after product approval. During the testing in China, a person e.g. as future Chinese distributor who is familiar to your SaMD might be useful to show how the software works to testing engineers. If medical software had cloud service to save data of patient, only a Chinese distributor could run this cloud. No data of patient goes abroad.

5.    Start compilation of technical dossier and type testing

All technical dossiers should be submitted electronically in Chinese. Based on general and special Chinese requirements of software, the dossier would be edited, revised, proved and released. At the same time manufacturers has to start type testing as early as possible. This is  unique Chinese other than registration in home country where SaMD is not exanimated by external lab. The functional parameters as stated in a tempate at software guidance will be tested conform to Chinese standard.

6.    Submit electronic technical dossier and acceptance – and technical review at NMPA

Prior to submission, foreign manufacturer has to notarise some original certificates and statements and sign all English documented as reference. After submission of technical dossier, the manufacturers may get an acceptance notification in 5 days if some documents in dossier are missing. After acceptance of dossier, NMPA begins technical review after which manufacturers have one year time to address technical deficiency till final approval.

7.    Distribution medical device to users, UDI-Registration, Post-market activities

In China manufactures don’t need to register themselves after product approval. You get a product certificate of SaMD valid for next 5 years. It is better to register UDI for class III SaMD immediately after product approval. As of this date you may distribute SaMD in Chinese market. Typically there is some obligatory for manufacturers to monitor the product in term of adverse events, recalls, periodic risk evaluation report, annual QM report.

8.    Next registration of new significant software release

SaMD is also under change assessment. The typical significant changes to trigger next change registration are significant cybersercurity and release of next main software version which normally adjusted by the first letter of software version depending on naming of software version. Otherwise manufactures have to renewal their certificate every 5 years.

Contact us to have a professional registration evaluation and marketing strategy of your SaMD. It is way wise to kick a complex registration project off with risk-based approach with actions already analysed and prepared.