Standards for NMPA Medical Device Registration
This selection covers the standards that appear most often in NMPA registration files for medical devices: electrical safety and EMC for active devices, quality and risk management, biocompatibility, sterilization, labelling symbols and software. Every edition listed below is the one currently in force; status was checked against the official SAMR national standards database and the industry standards portal on 27 October 2026.
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1. GB 9706.1-2020
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Status: In force since 1 May 2023 (Mandatory national standard). Replaces GB 9706.1-2007 and GB 9706.15-2008.
Page: https://chinastandards.org/standards/gb-9706-1-2020
About this standard
The Chinese adoption of IEC 60601-1 and the foundation of safety testing for every active medical device registered with NMPA. It sets the general requirements for basic safety and essential performance of medical electrical equipment and systems: protection against electrical, mechanical, radiation and thermal hazards, marking and accompanying documents, programmable systems (PEMS) and ME systems. Type-test reports issued by NMPA-recognised testing centres are built on this standard, together with the collateral (YY 9706.1xx) and particular (GB 9706.2xx) parts.
Table of contents
1 Scope, object and related standards
2 Normative references
3 Terminology and definitions
4 General requirements
5 General requirements for testing ME equipment
6 Classification of ME equipment and ME systems
7 ME equipment identification, marking and documents
8 Protection against electrical hazards from ME equipment
9 Protection against mechanical hazards of ME equipment and ME systems
10 Protection against unwanted and excessive radiation hazards
11 Protection against excessive temperatures and other hazards
12 Accuracy of controls and instruments and protection against hazardous outputs
13 Hazardous situations and fault conditions for ME equipment
14 Programmable electrical medical systems (PEMS)
15 Construction of ME equipment
16 ME systems
17 Electromagnetic compatibility of ME equipment and ME systems
Annex A to Annex M (general guidance and rationale, sequence of testing, marking and labelling, symbols, leakage current measurement, flammable anaesthetic mixtures, PEMS life cycle, ME systems, insulation paths, winding wires, pollution degrees)
2. YY 9706.102-2021
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
Status: In force since 1 May 2023 (Mandatory industry standard). Replaces YY 0505-2012.
Page: https://chinastandards.org/standards/yy-9706-102-2021
About this standard
The electromagnetic compatibility (EMC) collateral standard to GB 9706.1-2020, based on IEC 60601-1-2. It defines the emission limits a device must respect and the immunity it must show (electrostatic discharge, radiated and conducted RF fields, fast transients, surges, voltage dips and interruptions) without losing basic safety or essential performance. An EMC test report against this standard is part of the registration file for active devices; it entered into force on the same day as GB 9706.1-2020.
Table of contents
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 Identification, marking and documents
6 Electromagnetic compatibility of ME equipment and ME systems (emission and immunity requirements and tests)
Informative annexes, including: guide to marking and labelling requirements; example completion of the test tables; classification according to GB 4824; application of particular standards; electromagnetic environments; exemption of non-ME equipment in ME systems from EMC testing; mapping to YY 0505-2012
3. GB/T 42061-2022
Medical devices - Quality management systems - Requirements for regulatory purposes
Status: In force since 1 November 2023 (Recommended national standard). Replaces YY/T 0287-2017 (withdrawn 31 October 2023).
Page: https://chinastandards.org/standards/gb-t-42061-2022
About this standard
The Chinese adoption of ISO 13485:2016. It specifies the quality management system a manufacturer needs in order to show that its devices consistently meet customer and regulatory requirements: documentation and the medical device file, management responsibility, resources and work environment, design and development, purchasing, production, sterile devices, and measurement and improvement. It is the QMS reference used alongside China's Good Manufacturing Practice for medical devices.
Table of contents
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system (4.1 General requirements; 4.2 Documentation requirements, including the medical device file)
5 Management responsibility
6 Resource management (including work environment and contamination control)
7 Product realization (7.1 Planning; 7.2 Customer-related processes; 7.3 Design and development; 7.4 Purchasing; 7.5 Production and service provision; 7.6 Control of monitoring and measuring equipment)
8 Measurement, analysis and improvement (8.1 General; 8.2 Monitoring and measurement; 8.3 Control of nonconforming product; 8.4 Analysis of data; 8.5 Improvement)
4. GB/T 42062-2022
Medical devices - Application of risk management to medical devices
Status: In force since 1 November 2023 (Recommended national standard). Replaces the industry standard YY/T 0316-2016.
Page: https://chinastandards.org/standards/gb-t-42062-2022
About this standard
The Chinese adoption of ISO 14971:2019. It sets out the terminology, principles and process for managing the risks of medical devices, including software as a medical device and IVDs: risk analysis, evaluation and control, benefit-risk analysis, evaluation of overall residual risk, and production and post-production monitoring. The risk management file it requires underpins the safety evidence in an NMPA registration dossier.
Table of contents
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for risk management system
5 Risk analysis
6 Risk evaluation
7 Risk control
8 Evaluation of overall residual risk
9 Risk management review
10 Production and post-production activities
Annex A Rationale for requirements
Annex B Risk management process for medical devices
Annex C Fundamental risk concepts
5. GB/T 16886.1-2022
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Status: In force since 1 May 2023 (Recommended national standard). Replaces GB/T 16886.1-2011.
Page: https://chinastandards.org/standards/gb-t-16886-1-2022
About this standard
The Chinese adoption of ISO 10993-1:2018 and the starting point of every biocompatibility assessment. It categorizes devices by the nature and duration of body contact, and sets out how existing data, chemical information and gap analysis lead to the selection of biological endpoints and tests. Its endpoint table (Annex A) is the reference used to justify which biological tests are, or are not, included in a registration file.
Table of contents
1 Scope
2 Normative references
3 Terms and definitions
4 General principles applying to biological evaluation of medical devices
5 Categorization of medical devices (by nature of body contact; by duration of contact)
6 Biological evaluation process (physical and chemical information; gap analysis and selection of endpoints; biological testing)
7 Interpretation of biological evaluation data and overall biological risk assessment
Annex A Endpoints to be addressed in a biological risk assessment
Annex B Guidance on the conduct of biological evaluation
6. GB/T 16886.5-2017
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Status: In force since 1 July 2018 (Recommended national standard). Replaces GB/T 16886.5-2003.
Page: https://chinastandards.org/standards/gb-t-16886-5-2017
About this standard
The Chinese adoption of ISO 10993-5:2009. It describes how to assess the in vitro cytotoxicity of medical devices by exposing cultured cells to the device or its extracts, directly or through diffusion, and how to evaluate the results. Cytotoxicity is required for virtually every patient-contacting device, which makes this one of the most frequently cited test standards in registration files.
Table of contents
1 Scope
2 Normative references
3 Terms and definitions
4 Sample and control preparation
5 Cell lines
6 Culture medium
7 Preparation of cell stock culture
8 Test procedures
9 Test report
10 Assessment of results
Annex A Neutral red uptake (NRU) cytotoxicity test
Annex B Colony formation cytotoxicity test
Annex C MTT cytotoxicity test
Annex D XTT cytotoxicity test
7. GB/T 16886.10-2024
Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Status: In force since 1 September 2025 (Recommended national standard). Replaces GB/T 16886.10-2017.
Page: https://chinastandards.org/standards/gb-t-16886-10-2024
About this standard
The Chinese adoption of ISO 10993-10:2021, covering skin sensitization only (irritation now sits in GB/T 16886.23). It applies a step-wise approach, from material and chemical information to animal testing, and describes the murine local lymph node assay, the guinea pig maximization test and the Buehler closed-patch test, with the factors that affect their outcome. Sensitization is one of the three core biocompatibility endpoints for patient-contacting devices.
Table of contents
1 Scope
2 Normative references
3 Terms and definitions
4 General principles - step-wise approach
5 Pretest considerations (types of material; information on chemical composition)
6 Skin sensitization tests (choice of test methods; murine local lymph node assay; guinea pig assays; guinea pig maximization test; closed-patch (Buehler) test)
8. GB 18279-2023
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Status: In force since 1 October 2026 (Mandatory national standard). Replaces GB 18279.1-2015 and GB/T 18279.2-2015.
Page: https://chinastandards.org/standards/gb-18279-2023
About this standard
The mandatory standard for ethylene oxide sterilization, the most widely used method for single-use sterile devices, based on ISO 11135. It covers the whole life of an EO process: sterilizing agent and equipment characterization, product and process definition, validation, routine monitoring and control, product release and maintenance of process effectiveness. It became mandatory on 1 October 2026, so sterilization validations in new and renewed registrations must now refer to it.
Table of contents
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
5 Characteristics of the sterilizing agent
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
9. YY/T 0466.1-2023
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Status: In force since 15 September 2025 (Recommended industry standard). Replaces YY/T 0466.1-2016.
Page: https://chinastandards.org/standards/yy-t-0466-1-2023
About this standard
The Chinese adoption, with modifications, of ISO 15223-1:2021. It specifies the symbols used on medical devices, their packaging and accompanying information (manufacturer, lot, expiry, sterilization method, single use, consult instructions for use and many others), together with rules and examples for combining them. It is the reference for symbols on labels and IFUs prepared for the Chinese market.
Table of contents
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements (symbols to be adopted in the future; how to use; other symbols)
5 Symbols
Appendix A Guidelines and examples for using symbols, including multiple symbols
Appendix B Use of general prohibition symbols and negative symbols
10. YY/T 0664-2020
Medical device software - Software life cycle processes
Status: In force since 1 September 2021 (Recommended industry standard). Replaces YY/T 0664-2008.
Page: https://chinastandards.org/standards/yy-t-0664-2020
About this standard
The Chinese adoption, with modifications, of IEC 62304:2006 with Amendment 1:2015. It defines the life cycle processes for medical device software and software in medical devices: safety classification, development, maintenance, software risk management, configuration management and problem resolution. It is the reference behind the software documentation that NMPA expects for any device that contains or is software.
Table of contents
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements (quality management system; risk management; software safety classification; legacy software)
5 Software development process
6 Software maintenance process
7 Software risk management process
8 Software configuration management process
9 Software problem resolution process
Annex A Rationale for the requirements
Annex B Guidance on the provisions
Annex C Relationship to other standards
Annex D Implementation
