News Update - 11-16~11-22

Department

Update

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NMPA

National Medical Products Administration Reports Six Cases of Illegal Online Sales of Medical Devices

Abstract:

1. Selling medical devices on online platforms without notifying the competent drug regulatory authority as required

2. Selling Class III medical devices on online platforms without authorization

3. Selling unregistered Class II medical devices without establishing and implementing a purchase inspection record system

4. Selling Class II medical devices on online platforms without completing the required Class II medical device business filing

5. Selling medical devices on online platforms with non-compliant instructions and labels

6. Selling Class I medical devices on online platforms without displaying required filing information and failing to rectify as mandated

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Xu Jinghe Conducts Research on Medical Device Regulation in Chongqing

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Infographic Poster | Series 7: Interpretation of the Medical Device Production Quality Management Specifications

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Infographic Poster | Series 8: Interpretation of the Medical Device Production Quality Management Specifications

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Infographic Poster | Series 9: Interpretation of the Medical Device Production Quality Management Specifications

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Infographic Poster | Series 10: Interpretation of the Medical Device Production Quality Management Specifications

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Infographic Poster | Series 11: Interpretation of the Medical Device Production Quality Management Specifications

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Beckman Coulter, Inc. Initiates Voluntary Recall of DxH Diluent for Blood Cell Analysis Outside the United States

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Cardinal Health 200, LLC Initiates Voluntary Recall of Kendall SCD 700 Sequential Compression System Overseas

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Micro Therapeutics, Inc. DBA ev3 Neurovascular Initiates Voluntary Recall of Riptide™ Large Bore Aspiration Tubing for Single-Use External Suction Overseas

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Siemens Healthcare Diagnostics Inc. is conducting a voluntary recall of the CLINITEK Novus Automated Urine Chemistry Analyzer outside the United States.

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CMDE

When conducting biocompatibility evaluations of absorbable hemostatic products according to GB/T 16886.1, how should the duration of product-to-human contact be determined?  

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NIFDC

Notice Regarding the Solicitation of Collaborative Calibration Units for National Reference Materials of IgG Antibody Detection Reagents for Hydatid Disease

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Notice Regarding the 2025 Public Awareness Training Session for Standards Issued by the National Technical Committee for Standardization of Medical Device Quality Management and General Requirements

Abstract:

YY/T 1960—2025 Medical Devices — Information Provided by the Manufacturer

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