News Update - 0111~0117

Department

Update

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NMPA

Announcement of the National Medical Products Administration on the Approval of Registration for 388 Medical Device Products (December 2025) (No. 10 of 2026)

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CMDE

Public Notice of Review Results for Innovative Medical Device Special Review Applications (No. 2, 2026)

Abstract:

1. Product Name: Pelvic Fracture Surgery Planning Software

Applicant: Beijing Rosenbot Technology Co., Ltd.

2. Product Name: Magnetic Resonance Imaging Enhancer

Applicant: Qingchaozhuoying (Beijing) Medical Technology Co., Ltd.

3. Product Name: Decellularized Vaginal Tissue Repair Material

Applicant: Dobuwoqi Biomedical Technology (Jiangsu) Co., Ltd.

4. Product Name: Total Hip Replacement Surgical Positioning Device

Applicant: Beijing Yimai Technology Co., Ltd.

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Public Notice of Review Results for Priority Review Applications of Medical Devices (No. 2, 2026)

Abstract:

Product Name: Human Tumor Multi-Gene Mutation Combined Detection Kit (High-Throughput Sequencing Method)

Applicant: Guangzhou Renstone Medical Laboratory Co., Ltd.

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Notice Regarding Solicitation of Information on Relevant Enterprises and Organizations to Participate in the Development of the “Guidance Principles for the Registration Review of Recombinant Collagen Products for Aesthetic Plastic Surgery”

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Notice Regarding the 60th Offline Training Session of the “Device Review Cloud Classroom”

Abstract:

1. Progress in the Review of Transcatheter Mitral Valve Repair/Replacement Devices

2. Technical Review Requirements and Key Considerations for Interventional Aortic Valve Systems

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Notice on Soliciting Information from Relevant Enterprises and Institutions for Participation in the Development and Revision of 8 Guidance Principles Including “Guidance Principles for the Registration Review of Treponema Pallidum Antibody Detection Reagents”

Abstract:

1. Treponema pallidum Antibody Detection Reagents

2. Norovirus Nucleic Acid Detection Reagents

3. Ureaplasma urealyticum Nucleic Acid Detection Reagents

4. Helicobacter pylori Antigen/Antibody Detection Reagents

5. Anti-Human Globulin Detection Reagents

6. Enterovirus Nucleic Acid Detection Reagents

7. Mycobacterium tuberculosis Specific Cellular Immune Response Detection Reagents

8. Tumor-Related Mutation Gene Detection Reagents (High-Throughput Sequencing Method) Performance Evaluation

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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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Regarding the fatigue performance research of abutment-type products, how should the research materials and product technical requirements be studied and specified?

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NIFDC

Notice on Soliciting Drafting and Verification Units for the National Standard Plan on Gastrointestinal Ultrasound Contrast Media

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Notice on Soliciting Proposals for Preliminary Approval of Standards by the National Technical Committee for Standardization of Quality Management and General Requirements for Medical Devices in 2027

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Forwarding the Notice from the Medical Electronic Instruments Sub-Technical Committee of the National Technical Committee for Standardization of Medical Electrical Equipment Regarding the Solicitation of Pre-Project Proposals for Standards in the Medical Electronic Instruments Field for 2027

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Notice from the Office of the China National Institute for Food and Drug Control Regarding the Recruitment of Domestic Expert Panel Members for International Standards on Artificial Intelligence Medical Devices

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Notice from the Office of the China National Institute for Food and Drug Control Regarding the Solicitation of Proposals for Preliminary Approval of Medical Device Standards for Human Assisted Reproductive Technology in 2027

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Notice from the Office of the China National Institute for Food and Drug Control Regarding Solicitation of Proposals for Preliminary Approval of Medical Device Standards for Medical Additive Manufacturing Technology in 2027

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CMDE Yangtze River Delta Center

Notice Regarding the 60th “Device Review Cloud Classroom” Offline Training Session (Yangtze River Delta Branch)

Abstract:

1. Review Progress of Transcatheter Mitral Valve Repair/Replacement Devices

2. Technical Review Requirements and Key Considerations for Interventional Aortic Valve Systems

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CMDE Greater Bay Area Center

Notice from the Greater Bay Area Sub-center of the National Medical Products Administration Regarding Quick Q&A Services

Abstract:

Guidance and clarification for applicants regarding current publicly available medical device regulations, rules, normative documents, technical guidance principles, and related application procedures prior to registration submissions.

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