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News Update - 0720~0726

发布时间:2026-07-27阅读量:7来源:

Department

Update

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NMPA

Notice on Publicly Soliciting Comments on Three Informatization Standards Including the Technical Guide for Typical Application of Unique Device Identification (Medical Device Registrants, Filers and Manufacturers) (Draft for Comment)

Abstract:

1.Technical Guide for Typical Application of Unique Device Identification (Medical Device Registrants, Filers and Manufacturers) (Draft for Comment)

2.Technical Guide for Typical Application of Unique Device Identification (Medical Device Distributors) (Draft for Comment)

3.Technical Guide for Typical Application of Unique Device Identification (Medical Device Users) (Draft for Comment)

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Announcement of the National Medical Products Administration on Issuing the Amendments to Four Medical Device Industry Standards Including YY 0830—2011 Ultrasound Therapy Equipment for Superficial Tissue (No. 68 of 2026)

Abstract:

1.Amendment No. 1 to the Medical Device Industry Standard YY 0830—2011 Ultrasound Therapy Equipment for Superficial Tissue

2.Amendment No. 1 to the Medical Device Industry Standard YY/T 1120—2021 Dentistry — Operating Lights

3.Amendment No. 1 to the Medical Device Industry Standard YY/T 1737—2020 Analytical Methods for Bioburden Control Levels of Medical Devices

4.Amendment No. 1 to the Medical Device Industry Standard YY/T 1755—2021 Dentistry — Sandblasting Handpieces and Sandblasting Powders

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CMDE

Notice on Holding the 83rd Session of the "CMDE Cloud Classroom" Offline Training Course

Abstract:

1.Introduction to Review Focus Points of the Guideline for Registration Review of Posterior Spinal Internal Fixation Systems

2.Guideline for Technical Review of Clinical Evaluation Quality Control of Spinal Implants Registration

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Notice of the Center for Medical Device Evaluation, NMPA on Issuing 57 Guidelines Including the Guideline for Registration Review of Magnetocardiography Signal Acquisition Equipment (No. 24 of 2026)

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NIFDC

Forwarded Notice on Conducting the Survey on Implementation Evaluation of the Industry Standard YY 0450.1—2020 Sterile Single-Use Intravascular Catheter Accessories — Part 1: Introducers

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Forwarded Notice on Convening the 2026 Medical Ultrasound Standards Promotion Meeting

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SAC

Notice on Soliciting Comments on 10 Proposed Mandatory National Standard Projects Including Implants for Surgery — Metallic Materials — Part 4: Cast Cobalt-Chromium-Molybdenum Alloy

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