December 2021 Regulatory Roundup for Medical Device Mandatory Standards

On December 14, 2021, the NMPA (National Medical Products Administration) published a draft list of 76 standards associated to GB 9706.1-2020 to solicit public comments. The GB 9706.1-2020 medical electrical equipment Part 1: General requirements for basic safety and basic performance was issued on April 9, 2020, and will be implemented on May 1, 2023. Aside from GB 9706.1-2020 itself, the draft list consists of 68 specialized standards and 7 collateral standards. According to the implementation measures proposed by the NMPA,

• The date of implementation for GB 9706.1-2020 and its collateral standards will be May 1, 2023.

• Specialized standards under GB9706.1-2020 are indicated as standards with special requirements which will be further clarified when the draft is finalized.

On December 1, 2021, the Standardization Administration approved and issued (No.15-2021) 8 national standards for medical devices:

1. GB 9706.202-2021 Medical electrical equipment – Part 2-2: Particular requirements for basic safety and basic performance of high frequency surgical equipment and high frequency accessories
2. GB 9706.213-2021 Medical electrical equipment – Part 2-13: Particular requirements for the basic safety and basic performance of anesthesia workstations
3. GB 9706.218-2021 Medical electrical equipment – Part 2-18: Particular requirements for the basic safety and basic performance of endoscopic equipment
4. GB 9706.224-2021 Medical electrical equipment – Part 2-24: Particular requirements for the basic safety and basic performance of infusion pumps and infusion controllers
5. GB 9706.225-2021 Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and basic performance of electrocardiographs
6. GB 9706.236-2021 Medical electrical equipment – Part 2-36: Particular requirements for the basic safety and basic performance of extracorporeal lithotripsy equipment
7. GB 11236-2021 Technical requirements and test methods of copper IUD
8. GB 14232.4-2021 Plastic bag containers for human blood and blood components – Part 4: single blood bag system with special components

On December 10, 2021, the NMPA approved and issued (No.144-2021) 19 industry standards for medical devices:

1. YY/T 1747-2021 Neurovascular implants Intracranial artery stents
2. YY/T 1784-2021 Blood gas analyzer
3. YY/T 1789.2-2021 In Vitro Diagnostic Test System Performance Evaluation Method Part 2: Accuracy
4. YY/T 1791-2021 Hepatitis B virus e antibody detection kit (luminescence immunoassay)
5. YY/T 1801-2021 Fetal chromosome aneuploidy trisomy 21, trisomy 18 and trisomy 13 detection kit (high-throughput sequencing method)
6. YY/T 1820-2021 Specific antinuclear antibody IgG detection kit (Western blotting)
7. YY/T 1824-2021 EB virus nucleic acid detection kit (fluorescence PCR method)
8. YY/T 1825-2021 Red blood cell and white blood cell count reference measurement procedure fixed value result measurement uncertainty evaluation guide
9. YY/T 1826-2021 Group B Streptococcus Nucleic Acid Detection Kit (Fluorescence PCR Method)
10. YY/T 1828-2021 Anti-Mullerian hormone determination kit (chemiluminescence immunoassay)
11. YY/T 1831-2021 Syphilis spirochete antibody detection kit (immunochromatographic method)
12. YY/T 1836-2021 Respiratory virus multiple nucleic acid detection kit
13. YY/T 0500-2021 Cardiovascular implants: Vascular prostheses – Tubular vascular grafts and vascular patches
14. YY/T 0647-2021 Passive surgical implants: Specific requirements for breast implants
15. YY/T 0701-2021 Calibrator for blood analyzer
16. YY/T 1160-2021 Carcinoembryonic Antigen (CEA) Assay Kit
17. YY/T 1164-2021 Human chorionic gonadotropin (HCG) detection kit (colloidal gold immunochromatographic method)
18. YY/T 1180-2021 Human Leukocyte Antigen (HLA) Genotyping Test Kit
19. YY/T 1204-2021 Kit for determination of total bile acid

The code name of the mandatory national standard is “GB”, and the recommended national standard is “GB/T”. The code name of the mandatory industry standard is “YY”, and the code name of the recommended industry standard is “YY/T”. Contact Cisema if you would like to learn more about the compliance requirements for your medical product in China.

By Alice Liu and Jacky Li.