News Update - 0811~0817

Department

Update

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NMPA

Announcement of the National Medical Products Administration on Issuing 46 Medical Device Industry Standards Including Dentistry — Light Curing Units (No. 76 of 2026)

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Announcement on the Work Schedule for Pre-Acceptance Technical Consultation on Medical Device Registration for September–October 2026 (No. 375)

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Announcement of the National Medical Products Administration on Suspending the Import, Distribution and Use of Paclitaxel-Eluting PTA Balloon Catheters Manufactured by German OCCAM Medical GmbH (No. 73 of 2026)

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CMDE

Notice on Holding the 86th Session of the "CMDE Cloud Classroom" Offline Training Course

Abstract：

1.Analysis of Key Elements in Clinical Trial Design for Pathogen Nucleic Acid Detection Reagents

2.Discussion on Key Issues in Clinical Trials of Upper Respiratory Tract Pathogen Detection Reagents

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Does the intended use of a single-use peripheral nerve block puncture needle need to specify the manufacturer, model, and software version of the devices used with it?

Abstract：

This product is a single-use consumable, generally used with a nerve plexus stimulator. A combined use validation report must be submitted in the research data. The intended use does not need to specify the information of the devices used with it, but the manufacturer, model, software version, and other information of the validated compatible devices must be clearly stated in the instructions for use.

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If an active medical device main unit and its dedicated accessories have been separately approved for registration with the intended combination clearly specified, and the accessory's registration certificate has been approved to add a new model, does the main unit need to undergo a change registration?

Abstract：

When the main unit is used with new accessories, its software, product technical requirements, etc. usually change. A change registration is required, and the corresponding registration submission materials for the change must be submitted, including but not limited to research data related to combined use, software update research data, a comparison table of changes to product technical requirements and the corresponding test reports, clinical evaluation data, and quality management system documentation. The registrant shall submit the appropriate registration materials based on the nature of the change.

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NIFDC

Forwarded Notice of the National Technical Committee on Anesthesia and Respiratory Equipment of Standardization Administration of China on Soliciting Drafting and Verification Units for Two Proposed Recommended National Standards

Abstract：

1.Anaesthetic and Respiratory Equipment — Air Entrainment Devices

2.Anaesthetic and Respiratory Equipment — Breathing Therapy Tubing and Connectors

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Forwarded Notice on Soliciting Drafting Units for Four Recommended National Standard Development Projects Including Small-Bore Connectors for Liquids and Gases in Healthcare Applications — Part 1: General Requirements

Abstract：

1.Small-Bore Connectors for Liquids and Gases in Healthcare Applications — Part 1: General Requirements

2.Small-Bore Connectors for Liquids and Gases in Healthcare Applications — Part 2: Connectors for Breathing Applications

3.Small-Bore Connectors for Liquids and Gases in Healthcare Applications — Part 5: Connectors for Limb Cuff Inflation Applications

4.Small-Bore Connectors for Liquids and Gases in Healthcare Applications — Part 20: Common Test Methods

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Forwarded Notice on Convening the Validation Meeting for the National Standard Project of Sterilization of Health Care Products — Moist Heat — Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices

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Forwarded Notice on Soliciting Participating Drafting and Verification Units for the Mandatory National Standard Project of Implants for Surgery — Metallic Materials — Part 4: Cast Cobalt-Chromium-Molybdenum Alloy

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YRDCMDEI

Notice on Holding the 86th Session of the "CMDE Cloud Classroom" Offline Training Course (Yangtze River Delta Sub-Venue)

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