News Update - 1130~1206

Department

Update

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NMPA

Announcement of the National Medical Products Administration on the Cancellation of Medical Device Registration Certificates for Rigid Gas Permeable Contact Lenses and 8 Other Devices (No. 114 of 2025)

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China Pharma News Lounge | Does Combining Ablation Therapy with Medication Improve Lung Cancer Outcomes?

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Olympus Medical Corporation Olympus Medical Systems Corporation Initiates Voluntary Recall of Single-Use Ligation Devices

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Medtronic Inc. Initiates Voluntary Recall of Activated Clotting Time Test Kit (Coagulation Method) HR-ACT Cartridge (Overseas)

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Balt Extrusion SAS Initiates Voluntary Recall of Micro Guidewires (Overseas)

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Olympus Medical Corporation Initiates Voluntary Recall of Single-Use High-Frequency Loop Electrosurgical Units (Overseas)

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Smith & Nephew, Inc. Initiates Voluntary Recall of Polylactic Acid Hydroxyapatite Screws (Overseas)  

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Hologic, Inc. Initiates Voluntary Recall of CytoLyt Solution (Overseas)

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CMDE

Does the surgical planning software included in surgical navigation positioning equipment need to be specified in the structure of the registration certificate?  

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SAC

Notice of the Standardization Administration of China on Issuing the 11th Batch of Recommended National Standards Plan for 2025 and Related Foreign Language Edition Plans

Abstract:

1. Artificial Intelligence Medical Devices—Quality Requirements and Evaluation—Part 2: General Requirements for Datasets

2. Artificial Intelligence Medical Devices—Quality Requirements and Evaluation—Part 3: General Requirements for Data Annotation

3. Artificial Intelligence Medical Devices—Quality Requirements and Evaluation—Part 4: Traceability

4. Artificial Intelligence Medical Devices—Quality Requirements and Evaluation—Part 5: Pre-trained Models

5. Artificial Intelligence Medical Devices—Quality Requirements and Evaluation—Part 6: Synthetic Data

6. Artificial Intelligence Medical Devices—Quality Requirements and Evaluation—Part 7: Installation Verification

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No. 33 of 2025 2025-12-02

Abstract:

1. GB/T 14233.2-2025 Test Methods for Medical Infusion, Transfusion, and Injection Devices — Part 2: Biological Test Methods

Replaces: GB/T 14233.2-2005

Implementation Date: 2027/1/1

2. GB/T 18280.2-2025 Sterilization of Medical Devices - Radiation - Part 2: Establishing Sterilizing Dose

Replaces: GB 18280.2-2015

Implementation Date: 2027/7/1

3. GB/T 18280.3-2025 Sterilization of Medical Devices - Radiation - Part 3: Guidance on Dose Measurement for Development, Validation, and Routine Control

Replaced by: GB/T 18280.3-2015

Implementation Date: 2027/7/1

4. GB/T 18988.2-2025 Radionuclide Imaging Equipment - Performance and Test Requirements - Part 2: Planar, whole-body, and tomographic gamma cameras

Replaces: GB/T 18989-2013, GB/T 18988.2-2013, GB/T 18988.3-2013

Implementation Date: 2027/7/1

5. GB/T 19042.7-2025 Evaluation and Routine Tests for Medical Imaging Departments - Part 3-7: Acceptance and Stability Tests for Imaging Performance of Dental Cone Beam Computed Tomography X-ray Equipment

Replaced Standards: N/A

Implementation Date: 2027/1/1

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FDA

FDA Approves Nerve Scaffold for the Treatment of Sensory Nerve Discontinuity

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MDR

Monitoring of availability of medical devices on the EU Market - Study overview and 2nd survey results

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Malaysia

ANNOUNCEMENT PUBLIC COMMENT FIRST EDITION GUIDANCE DOCUMENT: DEFINITIONS OF MEDICAL DEVICES

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ANNOUNCEMENT PUBLIC COMMENT FIRST EDITION GUIDANCE DOCUMENT: CHANGE MANAGEMENT FOR REGISTERED MEDICAL DEVICES

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UPDATE ON THE ENFORCEMENT DATE FOR MEDICAL DEVICE IMPORT PERMIT

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