News Update-0125~0131

Department

Update

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CMDE

Public Notice of Review Results for Priority Review Applications of Medical Devices (No. 4, 2026)

Abstract:

Product Name: Human Tumor Multi-Gene Detection Kit (Combined Probe-Anchored Polymerase Sequencing Method)

Applicant: Suzhou Geneplus Biomedical Engineering Co., Ltd.

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Notice Regarding the 62nd Offline Training Session of the “Cloud Classroom for Device Review”

Abstract:

1. Guidance Principles for Registration Review of Ophthalmic Laser Photocoagulation Devices

2. Guidance Principles for Registration Review of Intense Pulsed Light (IPL) Therapy Devices

3. Guidance Principles for Registration Review of Medical Device Optical Radiation Safety

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Public Notice on Candidates for the Sixth Batch of External Experts of the Medical Device Technical Review Center

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Can vascular occlusion products demonstrate their safety and efficacy for use in both arterial and venous vessels within the same clinical trial?  

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Overview of How to Submit Changes During Registration Amendments for In Vitro Diagnostic Reagents  

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When the calibration standard has a low mass value, what are the requirements for the homogeneity of the calibration standard in the product technical specifications?

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Can a single specification be selected to cover all declared products in the stability study of absorbable surgical sutures?  

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NIFDC

Forwarding the Notice from the Medical Equipment Sub-Technical Committee of the National Technical Committee for Standardization of Safety of Measuring, Control, and Laboratory Electrical Equipment Regarding the Convening of the GB 4793—2024 and GB/T 42125.1—2024 Standards Promotion and Training Seminar

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Calls for Project Proposals in the Following Fields:

1. Standards for Medical Ultrasound Equipment

2. Standards of the Technical Committee for Standardization of Medical Extracorporeal Circulation Equipment

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Forwarding the Notice from the National Standardization Technical Committee for Contraceptive and Obstetric/Gynecological Devices Regarding the Solicitation of Drafting and Verification Units for Proposed Industry Standard Development Projects in 2026

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Call for Drafting Units and Drafters for 2026 Standards in the Field of Reliability and Maintainability

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Call for Proposals for Preliminary Approval of Reliability and Maintainability Standards for 2027

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CMDE Yangtze River Delta Center

Pre-Notice Regarding the 2026 Series of Training Programs by the Yangtze River Delta Branch Center for Medical Devices

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NMPA

Notice on the 2026 Medical Device Industry Standard Formulation and Revision Plan Projects by the General Administration Department of the National Medical Products Administration

Abstract:

Among the standards under development, the following are noteworthy:

1. Application Guidelines for Medical Device Unique Identification

2. General Requirements for Quality of Real-World Data for Medical Devices

3. Surgical Implants—Implantable Sutures for Plastic Surgery

4. Preclinical Animal Studies for Medical Devices—Part 5: Rat Cecal-Abdominal Wall Adhesion Model for Evaluating the Efficacy of Anti-Adhesion Products for Pelvic and Abdominal Surgery

5. Laser Therapy Equipment—Thulium-Doped Fiber Laser Therapy Devices

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Notice from the General Administration Department of the National Medical Products Administration Regarding the Establishment of Two Medical Device Industry Standards: “Paradigm Design and Application Specifications for Medical Devices Utilizing Brain-Computer Interface Technology: Motor Function Restoration” and “Medical Devices Utilizing Brain-Computer Interface Technology: Invasive Devices - Reliability Verification Methods”

Abstract:

1. Medical Devices Utilizing Brain-Computer Interface Technology: Paradigm Design and Application Specifications for Motor Function Restoration

2. Medical Devices Utilizing Brain-Computer Interface Technology: Invasive Devices - Reliability Verification Methods

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Announcement on Adjustments to Consultation Services at the Administrative Reception Service Hall of the National Medical Products Administration (No. 366)

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Announcement No. 365 from the Administrative Reception Service Hall of the National Medical Products Administration Regarding the 2026 Spring Festival Holiday Arrangements

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