News Update - 251228 - 1231

Department

Update

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CMDE

Notice Regarding the 57th Offline Training Session of the “Cloud Classroom for Device Review”

Abstract:

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Notice on Soliciting Opinions on the "Registration Review Guidelines for Digital Polymerase Chain Reaction Analyzers (Draft for Comment)"

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Notice of the National Medical Products Administration's Medical Device Review Center on the Release of Two Registration Review Guidelines for Changes in In Vitro Diagnostic Reagents and Other Guidelines (No. 32 of 2025)

Abstract:

1. Guidelines for Review of Changes in In Vitro Diagnostic Reagents

2. Guidelines for Review of Registration of Tumor Companion Diagnostic Genetic Mutation Detection Reagents (Real-time Fluorescence Polymerase Chain Reaction Method) (Revised in 2025)

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Notice on Soliciting Opinions on the "Evaluation Key Points for Plasma Surgical Equipment (Draft for Comment)" and Other 9 Medical Device Technical Evaluation Key Points

Abstract:

1. Evaluation Criteria for Plasma Surgical Equipment (Draft for Comment)

2. Evaluation Criteria for Intravascular Radiofrequency Closure Generator (Draft for Comment)

3. Evaluation Criteria for Electric Linear Cutting and Sealing Device (Draft for Comment)

4. Evaluation Criteria for Varicose Vein Closure Gel Products (Draft for Comment)

5. Technical Evaluation Criteria for Tendon Repair Patch Products (Draft for Comment)

6. Evaluation Criteria for Teeth Whitening Materials (Draft for Comment)

7. Clinical Decision-making Technical Evaluation Criteria for Implantable Left Ventricular Assist Circulation System (Draft for Comment)

8. Clinical Trial Design Technical Evaluation Criteria for Implantable Left Ventricular Assist System (Draft for Comment)

9. Clinical Trial Design Technical Evaluation Criteria for Boron Neutron Capture Therapy System (Draft for Comment)

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