News Update - 1027~1031

Regulation

1.

Notice on Holding the 49th Off-line Tutorial Class of "Cloud Examining Class"

Abstract：

1. Guidance Principles for Registration Review of Brucella IgM/IgG Antibody Detection Reagents

2. Introduction to Registration Application Documentation Requirements for EB Virus Antibody Detection Reagents—Non-Clinical Data

3. Clinical Trial Requirements for EB Virus Antibody Detection Reagent

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Q&A

1.

Can a single registration unit for a multiplex upper respiratory tract infection pathogen antigen detection kit include products with different combinations?

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Standard

1.

Announcement No. 28 of 2025 on Chinese National Standards

Abstract:

1. Repealed Standard:

GB 11417.3-2012 Ophthalmic Optics - Contact Lenses - Part 3: Soft Contact Lenses

 GB 11417.2-2012 Ophthalmic Optics - Contact Lenses - Part 2: Rigid Contact Lenses

    Date of Repeal: November 1, 2028

Replaced by:

GB 11417.3-2025 Ophthalmic Optics - Contact Lenses - Part 3: Soft Contact Lenses

 GB 11417.2-2025 Ophthalmic Optics Contact Lenses Part 2: Rigid Contact Lenses

    2. Repealed Standard: GB 22457-2008 Prosthetic Fitting Services

 Date of Repeal: November 1, 2026

    Replaced by: GB 22457-2025 Prosthetic Fitting Services

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2.

Announcement of the National Medical Products Administration on the Release of 15 Recommended Medical Device Industry Standards Including YY/T 0910.2—2025 "Medical Electrical Equipment—Medical Imaging Display Systems—Part 2: Acceptance and Stability Tests for Medical Imaging Display Systems" (Announcement No. 106 of 2025)

Abstract:

1.Standard Developed:

YY/T 0910.2—2025 Medical Electrical Equipment Medical Imaging Display Systems Part 2: Acceptance and Stability Tests for Medical Imaging Display Systems

YY/T 1670.2—2025 Evaluation of Neurotoxicity of Medical Devices—Part 2: Neurocytotoxicity Test

YY/T 1983—2025 Dentistry Zirconia Dental Implants Dynamic Fatigue Testing

YY/T 1988—2025 Sports Medicine Implant Devices - Meniscus Suture Systems

YY/T 1989—2025 Medical Devices for Human Assisted Reproductive Technology—Determination of Sucrose, Glucose, Trehalose, and Fructose in Assisted Reproductive Fluids

YY/T 1990—2025 Artificial Intelligence Medical Devices - Cellular Pathology Image Analysis Software - Algorithm Performance Testing Methods

YY/T 1991—2025 Artificial Intelligence Medical Devices—Algorithm Performance Testing Methods for Stroke CT Image Analysis Software

YY/T 1992—2025 Robotic-Assisted Surgical Devices—Summarized Usability Testing Methods

YY/T 1993—2025 Robotic-Assisted Surgical Devices—Reliability Verification Methods

YY/T 1994—2025 Control Systems for Robot-Assisted Vascular Interventional Surgery

YY/T 1995—2025 Tissue Engineering Medical Devices—Cellular Biology Effect Evaluation Tests for Cartilage Scaffolds

2.Revised Standard:

YY/T 0915—2025 Dentistry Orthodontic Brackets and Buccal Tubes

YY/T 1469—2025 Portable Electric Infusion Pumps

YY/T 1539—2025 Medical Clean Benches

YY/T 1637—2025 Dentistry Magnetic Attachments

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