News Update - 1101~1115

Department

Update

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NMPA

NMPA Announcement on Releasing the Medical Device Quality Management Practice for Manufacturing (No. 107 of 2025)

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Revision and Release of the "Medical Device Quality Management Practice for Manufacturing"

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SAC

The 8th CIIE Sub-Forum "AI International Standards Empowering Industrial Upgrading" Held

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CDR-ADR

Tianjin Medical Device Adverse Event Monitoring Center Holds Exchange Meeting on "14th Five-Year Plan" Blood Glucose Meter Key Monitoring Risk Feedback

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NIFDC

Announcement Concerning the Accreditation for Inspection of the New GB 9706 Series Standards (November 2025)

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NIFDC Office Notice on Organizing Training Classes for Inspection Technology and Standardization of Frontier Medical Devices like Brain-Computer Interface

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Office Notice on Organizing Training on Frontier Technologies for Medical High-Throughput Sequencing

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Notice on Soliciting Collaborative Calibration Units for the National Reference Panel for Epstein-Barr Virus Nucleic Acid Detection Reagents

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Forwarded Notice from the Sub-technical Committee for Medical Electronic Instruments of the National Technical Committee for Medical Electrical Equipment on Convening the Deliberation Meeting for 3 Industry Standards including "Intravascular Shockwave Therapy Equipment"

Abstract:

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NIFDC Office Notice on Soliciting Participating Drafting Units for the Second Batch of National Standard Development and Revision Projects for Medical Devices Used in Human Assisted Reproductive Technology in 2025

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Forwarded Notice on Convening the 2025 Annual Meeting and Standard Deliberation Meeting of the Sub-technical Committee for Radiotherapy, Nuclear Medicine, and Radiation Dosimetry Equipment of the National Technical Committee for Medical Electrical Equipment

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Forwarded Notice from the Sub-technical Committee for Medical Electronic Instruments of the National Technical Committee for Medical Electrical Equipment on Convening the 2nd Session of the 6th Committee and Standard Deliberation Meeting

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Forwarded Notice on Convening the 2025 Annual Meeting and Standard Deliberation Meeting of the Sub-technical Committee for Medical Equipment of the National Technical Committee for Safety of Electrical Equipment for Measurement, Control, and Laboratory Use

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Forwarded Notice from the National Technical Committee for Anesthetic and Respiratory Equipment on Soliciting Drafting and Validation Units for 3 Recommended National Standard Plans

Abstract:

1. "Anesthetic and respiratory equipment — Cuff pressure indicators, controllers and regulators"

2. "Flow-control devices intended for connection to medical gas pipeline systems"

3. "Anesthetic and respiratory equipment — Breathing system components and connections"

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NIFDC Office Notice on Soliciting Participating Drafting and Validation Units for 2025 National Standards for Medical Robots

Abstract:

"Requirements and test methods for computer-assisted navigation system for robotically assisted orthopedic surgery"

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Notice on Publicly Soliciting Opinions on Adjustments to Parts of the "Medical Device Classification Catalog"

Abstract:

Adjustment of product description and intended use for 20-Traditional Chinese Medicine Devices-03-TCM Appliances-08-Moxibustion Appliancespinions on Adjustments to Parts of the "Medical Device Classification Catalog"

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Forwarded Notice on Convening the 2025 Industry Standard Deliberation Meeting of the National Technical Committee for Clinical Laboratory and In Vitro Diagnostic Systems

Abstract:

1. Development "KRAS Gene Mutation Detection Kit (Fluorescent PCR Method)"

2. Development "ALK Fusion/Rearrangement Gene Detection Kit (Fluorescence In Situ Hybridization Method)"

3. Development "Human Erythrocyte Irregular Antibody Detection Kit"

4. Development "Mycoplasma pneumoniae Nucleic Acid Detection Kit"

5. Development "Hepatitis C Virus Nucleic Acid Detection Kit"

6. Development "Hepatitis B Virus Nucleic Acid Detection Kit"

7. Development "In Vitro Diagnostic Medical Devices - Implementation Guide for Establishing Metrological Traceability - Part 1: Traceability to SI Units"

8. Revision "Automatic Urine Sediment Analyzer"

9. Revision "Cystatin C Assay Kit"

10. Development "Cortisol Assay Kit"

11. Development "Blood Ammonia Assay Kit"

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Forwarded Notice on Convening the 7th Inaugural Meeting, 2025 Year-End Abstract Meeting, and Training Session of the National Technical Committee for Clinical Laboratory and In Vitro Diagnostic Systems

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Forwarded SAC/TC110 Notice on Convening the 4th Annual Meeting of the 7th Committee for Surgical Implants and Standard Deliberation Meeting

Abstract:

1. Revision GB 4234.1—2017 "Implants for surgery — Metallic materials — Part 1: Wrought stainless steel"

2. Revision YY/T 0726—2020 "General requirements for instruments to be used in association with non-active surgical implants"

3. Revision YY/T 1565—2017 "Non-destructive testing of cast metallic surgical implants — Radiographic inspection"

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Forwarded SAC/TC110/SC1 Notice on Convening the 1st Annual Meeting of the 4th Committee for Orthopaedic Implants and Standard Deliberation Meeting

Abstract:

1. Revision YY/T 0920—2014 "Joint replacement implants — Requirements for performance evaluation of hip joint prostheses"

2. Development "Joint replacement implants — Finite element analysis method for knee joint prostheses"

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Forwarded Notice on Convening the 2025 TC10/SC1 Annual Meeting and Standard Deliberation Meeting

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NIFDC Office Notice on Convening the 4th Meeting of the 2nd Standardization Affiliated Group for Medical Devices Used in Human Assisted Reproductive Technology and Industry Standard Deliberation Meeting

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Forwarded Notice on Convening the 4th Annual Meeting of the 1st Standardization Affiliated Group for Traditional Chinese Medicine Devices and Standard Deliberation Meeting

Abstract:

1.Development "Traditional Chinese Medicine Devices - Cutaneous Needle - Part 2: Rolling Type"

2.Development "Medical Device Industry Standard YY/T 1490-2016 'Electrically Heated Moxibustion Equipment' Amendment No. 1"

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NIFDC Office Notice on Soliciting Participating Drafting and Validation Units for 2025 National Standards for Medical Robots

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Forwarded Notice on Convening the 1st Annual Meeting of the 4th Committee for Cardiovascular Implants and Standard Deliberation Meeting

Abstract:

Deliberation of Revision Project: "Cardiovascular implants — Endovascular devices — Part 4: Application of YY/T 1860.1 to coated endovascular devices"

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Forwarded Notice on Convening the 1st Annual Meeting of the 5th Subcommittee for Physical Therapy Equipment and Standard Deliberation Meeting

Abstract:

Deliberation of Revision Projects:

1. "General technical requirements for heat conduction physiotherapy equipment"

2. "Endovenous radiofrequency occlusion system"

3. "Magnetic stimulation equipment"

4. "YY 0060—2018 'Hot Compress Patch (Bag)' Medical Device Industry Standard Amendment No. 1"

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