News Update - 0118~0124

Department

Update

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CMDE

Notice Regarding Solicitation of Information on Enterprises and Institutions Participating in the Development of Technical Review Guidelines for Sodium Hyaluronate Injection Solutions for Skin Condition Improvement

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Notice on Soliciting Information from Relevant Enterprises and Institutions for Participating in the Development of Three Guidance Principles Including the “Guidance Principles for Registration Review of Picosecond Nd:YAG Laser Therapy Devices”

Abstract:

1. Guidance Principles for Registration Review of Picosecond Nd:YAG Laser Therapy Devices

2. Guidance Principles for Registration Review of Laser Photodynamic Therapy Devices

3. Guidance Principles for Registration Review of Hyperbaric Oxygen Chamber Equipment

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Notice on Soliciting Public Comments Regarding the Draft Registration Review Guidance Principles for Transcatheter Mitral Valve Clip Systems

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Notice Regarding the 61st Offline Training Session of the “Cloud Classroom for Device Review”

Abstract:

Interpretation of Technical Review Guidelines for the Registration of Facial Implants for Cosmetic Surgery

Key Considerations for Technical Review of Recombinant Collagen Facial Fillers for Cosmetic Aesthetics

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Notice on Soliciting Information from Relevant Enterprises and Institutions for Participating in the Development and Revision of 7 Guidance Documents and Review Criteria, Including the “Guidance on Registration Review for Hepatitis B Virus Surface Antigen Detection Reagents”

Abstract:

1. Guidance on Registration Review for Hepatitis B Virus Surface Antigen Detection Reagents

2. Guidance on Registration Review for Clinical Trials of Human Immunodeficiency Virus Antibody Detection Reagents for Consumer Self-Testing

3. Guidance Principles for Registration Review of Cervical Cancer Methylation Detection Reagents

4. Guidance Principles for Registration Review of Clinical Trials for Consumer-Self-Testing Respiratory Antigen Detection Reagents

5. Technical Review Points for Tumor Gene Sequencing Software

6. Principles and Technical Points for Constructing Reference Databases for Clinical Pathogenic Microorganism Analysis Based on Next-Generation Sequencing Technology

7. Review Points for Clinical Trial Data of Computer-Assisted Analysis Software for Cervical Cytology Digital Pathology Images

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Public Notice of Review Results for Priority Review Applications of Medical Devices (No. 3, 2026)

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Product Name: Medical Electron Linear Accelerator

Applicant: Beijing Leitaitengfei Medical Technology Co., Ltd.

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Infographic: Summary of Medical Device Technical Review Work in December 2025

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When the calibration standard has a low mass value level, 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

Dynamic Adjustment of Classification Catalogues to Support Scientific Regulation of Medical Devices

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SAC

National Standard for Classification and Assessment of Traditional Chinese Medicine Constitution Types Established and Released for the First Time

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