News Update - 0530~0605

Department

Update

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NMPA

Announcement of the National Medical Products Administration on the Issuance of the Procedures for Dynamic Adjustments to the Medical Device Classification Catalog (No. 53 of 2026)

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Announcement of the National Medical Products Administration on Matters Related to the Adjustment of Medical Device Classification (No. 52 of 2026)

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Interpretation of the Announcement on Adjustments to the Classification of Medical Devices

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CMDE

Notice on Holding the 76th Offline Tutorial Class of the “CMDE Cloud Classroom”

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Notice on Further Standardizing the Registration of Medical Device Master Files

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Notice on Soliciting Public Comments on Four Medical Device Registration Review Guidelines, Including the “Guidance on the Registration Review of Radiofrequency Ablation Devices (Draft for Comment)”

Abstract:

1.Guidance Principles for the Registration Review of Radiofrequency Ablation Devices (Draft for Comment)

2.Guidance Principles for the Registration Review of Cardiac Radiofrequency Ablation Devices (Draft for Comment)

3.Guidance Principles for the Registration Review of Cardiac Pulsed Electric Field Ablation Devices (Draft for Comment)

4.Guidance Principles for the Registration Review of Endoscopic Image Acquisition and Processing Devices (Draft for Comment)

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What factors should be considered regarding the structural composition and design of dental fiber posts?

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Regarding nucleic acid test kits for multiple respiratory pathogens, there are separate guidelines for influenza A and B virus test kits. How should these be interpreted?

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