News Update - 1123~1129

Department

Update

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NMPA

Notice of the National Medical Products Administration on Issuing the On-Site Inspection Guidance Principles for Quality Management of Online Sales of Medical Devices

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Medicine Insights | Series Interpretation (Part One): Announcement by the National Medical Products Administration on Measures to Optimize Full-Life-Cycle Regulatory Support for the Innovative Development of High-End Medical Devices

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CMDE

How should the primary endpoint (including follow-up duration) be considered in the clinical trial design for left atrial appendage occluders?

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Inclusivity Study of Hepatitis B Virus Surface Antigen Detection Reagents: Which Serotypes Should the Samples Cover?

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Infographic — Summary of Medical Device Technical Review Work in October 2025

Abstract:

1. Projects transferred in: 1,300; Projects transferred out: 1,322

2. Accepted registrations: 2,121; Filed modifications: 788

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NIFDC

Notice on Convening the Fourth Session of the Fourth Term of the National Technical Committee for Standardization of Quality Management and General Requirements for Medical Devices and the Standard Review Meeting

Abstract:

Review of the Recommended National Standard Project “Medical Devices — Part 1: Application of Usability Engineering to Medical Devices”

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