139 Standards Issued in 2024, Elevating Medical Device Regulations to Global Excellence

The NMPA released 49 national standards and 90 industry standards for medical devices and in vitro diagnostics (IVDs) in 2024. These standards were revised or newly established to assist manufacturers in local type testing, clinical evaluation, and regulatory submissions, etc.

The updated standards also aim to align more closely with international regulations. The NMPA has strengthened its collaboration with international standardization organizations, enhancing mutual recognition and consistency. Among the newly issued national and industry standards, 71 have adopted international standards. And China’s “ISO 7151:2024 General Requirements and Testing Methods for Non-cutting Articulated Surgical Instruments” has been approved for release. Furthermore, six international standards, including “AI-Based Medical Devices for Pulmonary Imaging—Algorithm Performance Testing Methods”, are expected to be published by NMPA in 2025.

Scope of the Standards

The newly issued standards cover various aspects of medical device regulation, including manufacturing methods, performance testing, biological evaluation, non-clinical and clinical test, and quality management systems for medical devices and IVDs.

Legal Enforcement

Industry Mandatory Standards are legally binding. Decree 739 Regulation on Supervision and Management of Medical Devices, the highest law governing medical device industry in China, mandates that “medical device shall meet the national mandatory standards; if there are no national mandatory standards, they shall comply with the industry mandatory standards”. The industry recommended standards are not legally binding but recommended by regulatory authorities.

For English version of the Decree 739 Regulation on Supervision and Management of Medical Devices, please email info@ChinaMedDevice.com.

National Standards

49 newly issued national standards are listed below:

1. GB 1588—2024: Medical Glass Thermometers
2. GB/T 19633.1—2024: Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems
3. GB/T 19633.2—2024: Packaging for Terminally Sterilized Medical Devices – Part 2: Requirements for Validation of Forming, Sealing, and Assembly Processes
4. GB/T 44059.1—2024: Medical Gas Pipeline Systems – Part 1: Pipeline Systems for Compressed Medical Gases and Vacuum
5. GB/T 12279.2—2024: Cardiovascular Implants – Artificial Heart Valves – Part 2: Surgical Implantable Artificial Heart Valves
6. GB/T 44138—2024: Cardiovascular Implants – Absorbable Implants
7. GB/T 12279.1—2024: Cardiovascular Implants – Artificial Heart Valves – Part 1: General Requirements
8. GB/T 43952—2024: Medical Supply Units
9. GB/T 16886.10—2024: Biological Evaluation of Medical Devices – Part 10: Tests for Skin Sensitization
10. GB/T 18457—2024: Stainless Steel Needle Tubing for the Manufacture of Medical Devices – Requirements and Test Methods
11. GB/T 42216.4—2024: Molecular In Vitro Diagnostic Examination – Pre-Analytical Process for Formalin-Fixed and Paraffin-Embedded Tissue – Part 4: In Situ Detection Techniques
12. GB/T 44353.1—2024: Animal-Derived Medical Devices – Part 1: Application of Risk Management
13. GB/T 44353.2—2024: Animal-Derived Medical Devices – Part 2: Control of Sourcing, Collection, and Handling
14. GB/Z 44363—2024: Pyrogenicity – Principles and Methods of Pyrogen Testing for Medical Devices
15. GB 16174.2—2024: Surgical Implants – Active Implantable Medical Devices – Part 2: Cardiac Pacemakers
16. GB 16174.1—2024: Surgical Implants – Active Implantable Medical Devices – Part 1: General Requirements for Safety, Marking, and Information Supplied by the Manufacturer
17. GB/T 36917.2—2024: Dentistry – Rotary Instruments for Laboratory Use – Part 2: Carbide Burs for Laboratory Use
18. GB/T 44671—2024: Basic Semen Examination – Requirements and Test Methods
19. GB/T 42080.3—2024: Molecular In Vitro Diagnostic Examination – Pre-Analytical Process for Frozen Tissue – Part 3: DNA Isolation
20. GB/T 44672—2024: In Vitro Diagnostic Medical Devices – International Harmonization of Requirements for Establishing Calibration Materials and Assigning Values to Human Samples
21. GB/T 18281.7—2024: Sterilization of Healthcare Products – Biological Indicators – Part 7: Guidance on Selection, Use, and Interpretation of Results
22. GB/T 44586.1—2024: In Vitro Diagnostic Medical Devices – Multiplex Nucleic Acid Detection – Part 1: Terms and General Requirements for Nucleic Acid Quality Assessment
23. GB/T 44585.1—2024: Application of Risk Management to IT-Networked Medical Devices – Part 1: Safety, Effectiveness, and Cybersecurity of Networked Medical Devices or Health Software During Implementation and Use
24. GB/T 44467—2024: Molecular In Vitro Diagnostic Examination – Pre-Analytical Process for Saliva – Extraction of Human DNA
25. GB/T 44469—2024: Dental Rotary Instruments – Laboratory Grinding Instruments
26. GB/T 44466—2024: Dentistry – Dentist’s Chair
27. GB/T 22750.2—2024: Surgical Implants – Ceramic Materials – Part 2: Zirconia-Toughened High-Purity Alumina-Based Composite Materials
28. GB/T 14233.3—2024: Test Methods for Medical Infusion, Transfusion, and Injection Equipment – Part 3: Microbiological Test Methods
29. GB/T 44875—2024: Tubal Ligation Rings – Technical Requirements and Test Methods
30. GB/T 44827—2024: Molecular In Vitro Diagnostic Examination – Pre-Analytical Process for Urine, Venous Serum, and Plasma Metabolomics
31. GB/Z 44877—2024: Sterilization of Medical Devices – Guide for the Release of Ethylene Oxide Sterilization Process Parameters
32. GB/T 44876—2024: Surgical Implants – Orthopedic Implants – General Requirements for Cleanliness
33. GB/T 22750.1—2024: Surgical Implants – Ceramic Materials – Part 1: High-Purity Alumina Ceramics
34. GB/T 13074—2024: Terminology for Blood Purification
35. GB 4234.12—2024: Surgical Implants – Metallic Materials – Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy
36. GB 4234.7—2024: Surgical Implants – Metallic Materials – Part 7: Wrought and Cold-Worked Cobalt-Chromium-Nickel-Molybdenum-Iron Alloy
37. GB 4234.3—2024: Surgical Implants – Metallic Materials – Part 3: Wrought Titanium-6Aluminum-4Vanadium Alloy
38. GB 4234.2—2024: Surgical Implants – Metallic Materials – Part 2: Pure Titanium
39. GB/T 19701.5—2024: Surgical Implants – Ultra-High Molecular Weight Polyethylene – Part 5: Morphological Evaluation Methods
40. GB/T 19701.3—2024: Surgical Implants – Ultra-High Molecular Weight Polyethylene – Part 3: Accelerated Aging Methods
41. GB/T 18281.8—2024: Sterilization of Healthcare Products – Biological Indicators – Part 8: Confirmation Methods for Reducing Biological Indicator Cultivation Time
42. GB/T 19701.2—2024: Surgical Implants – Ultra-High Molecular Weight Polyethylene – Part 2: Molding Materials
43. GB/T 19701.1—2024: Surgical Implants – Ultra-High Molecular Weight Polyethylene – Part 1: Powder
44. GB/T 18281.1—2024: Sterilization of Healthcare Products – Biological Indicators – Part 1: General Requirements
45. GB/T 18281.2—2024: Sterilization of Healthcare Products – Biological Indicators – Part 2: Biological Indicators for Ethylene Oxide Sterilization
46. GB/T 18281.5—2024: Sterilization of Healthcare Products – Biological Indicators – Part 5: Biological Indicators for Low-Temperature Steam Formaldehyde Sterilization
47. GB/T 18281.4—2024: Sterilization of Healthcare Products – Biological Indicators – Part 4: Biological Indicators for Dry Heat Sterilization
48. GB/T 18281.3—2024: Sterilization of Healthcare Products – Biological Indicators – Part 3: Biological Indicators for Moist Heat Sterilization
49. GB/T 12417.1—2024: Passive Surgical Implants – Bone Fixation and Joint Replacement Implants – Part 1: Special Requirements for Bone Fixation Implants

Industry Standards

In addition to national standards, 90 new industry standards were issued. These cover specialized areas such as:

• Performance testing for AI-assisted diagnostic devices
• Sterilization methods for surgical implants
• Material and safety requirements for cardiovascular implants

For a full list of the 90 industry standards, please email info@ChinaMedDevice.com.