In March of 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) released new guidance pertaining to registering medical device software in China. Referred to as the “Guiding Principles,” this new document provides technical considerations for 18 product categories including stand-alone software and software included in physical medical devices, including in-vitro medical devices. The new guidance can be found here in Chinese and here in English.

Basic Principles

The new guidance intends to provide manufacturers planning to register their medical device software in China with an understanding of how their software will be evaluated by the authorities. As with most countries, the NMPA’s review will look at the software life cycle (GB/T 20158-2006) to ensure manufacturers are taking appropriate risk mitigation steps to ensure safety throughout the product’s time on the market. The NMPA will look specifically at the design and verification process as this is equivalent to a physical device’s manufacturing process. Additionally, security, specifically cyber security, will also be evaluated in accordance with IMDRF/CYBER WG/N60FINAL : 20 20 , Principles and Practices for Medical Device Cybersecurity.

Technical Considerations

The guidance also outlines the various technical considerations medical device manufacturers should consider before registering their software in China. Depending on the product’s functions, some or all may need to be considered and evaluated.

The Technical Considerations outlined in the guidance include:

1. Registration Unit and Detection Unit
2. Basic Principles of Clinical Evaluation
3. Network Security
4. Cloud Computing
5. Mobile Computing
6. Artificial Intelligence
7. Human Factors and Availability
8. Interoperability
9. Measurement Functions
10. Remote Access and Control
11. General Computing Platform
12. Non-Medical Device Functions
13. Implantable Product Design Software
14. Terms of Use
15. Exception Handling
16. Functional Safety and Software Reliability
17. Implementation Requirements of GB/T 25000.51
18. Imported Medical Device Software

Standalone Software Technical Requirements

As part of the guidance, the CMDE had provided a Technical Requirements template for medical device software products. An outline of this template has been extracted for convenience but more information for each section can be found at the bottom of their guidance.

1. Product model/specification and its division description

1.1 Software Model Specifications

1.2 Software Release Version

1.3 Software Version Naming Rules

2. Performance indicators

2.1 General requirements

2.1.1 Function

2.1.2 Usage Restrictions

2.1.3 Input and output

2.1.4 Interface

2.1.5 Necessary software and hardware

2.1.6 Operating Environment

2.1.7 Performance Efficiency

2.1.8 Maximum concurrent number

2.1.9 User Interface

2.1.10 Messages

2.1.1 1 User Error Defense

2.1.1 2 Access Control

2.1.1 3 Copyright protection

2.1.14 Reliability

2.1.1 5 Maintainability

2.2 Special requirements ( if applicable )

2.3 Safety requirements ( if applicable )

3. Inspection method

4. Terminology/Definitions (if applicable)

Appendix

Which may include:

1. Architecture diagram
2. User interface diagram and main interface diagram
3. Physical topology