News Update - 251214~1220

Department

Update

link

NMPA

Working Meeting on Brain-Computer Interface Medical Devices Held

link

Announcement of the National Medical Products Administration on the Approval of Registration for 305 Medical Device Products (November 2025) (No. 121 of 2025)

link

Announcement by the National Medical Products Administration Regarding the Revocation of the Medical Device Registration Certificate for Peripheral Adjustable Bending Guide Catheters (No. 122 of 2025)

Abstract:

Company Name: Kangweining (Chongqing) Medical Technology Co., Ltd.

Product Name: Peripheral Adjustable Bending Guide Catheter

Falsified documentation was submitted.

link

Datex-Ohmeda, Inc. Voluntary Recall of Anesthesia System  

link

Roche Diagnostics GmbH Initiates Voluntary Recall of CleanCell Buffer Solution  

link

Olympus Medical Corporation Olympus Medical Systems Corporation Voluntary Recall of Single-Use Endoscopic Injection Needles, Single-Use Biopsy Forceps, Transparent Mucosal Suction Cups, Contrast Tubes, and Flexible Bronchoscopes  

link

Synthes GmbH is conducting a voluntary recall of single-use bone drills/saw blades/files.

link

Philips Medical Systems DMC GmbH is conducting a voluntary recall of the following medical devices: Digital Medical X-ray Radiography System Medical Diagnostic X-ray System Fluoroscopy Radiography X-ray Equipment

link

Tornier, Inc. Voluntary Recall of Tornier PerFORM Reversed Shoulder System Acromioclavicular Joint Components

link

Olympus Winter & Ibe GmbH Initiates Voluntary Recall of HF-Resection Electrodes

link

Boston Scientific Corporation is conducting a voluntary recall of Coyote OVER-THE-WIRE PTA Balloon Dilatation Catheters.

link

CMDE

Notice Regarding the Organisation of the 56th Offline Tutorial Session for the ‘Cloud Classroom for Device Review’

Abstract:

1. Introduction to Technical Review Requirements for Preclinical Research Data of Human Immunodeficiency Virus Antigen and Antibody Detection Reagents

2. Guidance Principles for Registration Technical Review of Pathogen-Specific M-Type Immunoglobulin Qualitative Detection Reagents (Revised Edition 2023)

3. Relevant Requirements for Clinical Trials of Rotavirus Antigen Detection Reagents  

link

Notice Regarding the Written Examination for the Open Recruitment of Contract Staff at the Medical Device Technology Review Centre for the Second Half of 2025

link

Notice Regarding Matters Pertaining to the 2025 Open Recruitment Interviews Issued by the Beijing-Tianjin-Hebei Sub-Centre, Central China Sub-Centre, and Southwest Sub-Centre of the Drug and Medical Device Evaluation and Inspection Division National Medical Products Administration  

link

Notice of the Centre for Medical Devices of the National Medical Products Administration on the Issuance of Four Guidance Principles Including the Registration Review Guidance Principles for HLA-B*27 Gene Detection Reagents (No. 29 of 2025)

Abstract:

1. HLA-B*27 Gene Detection Reagents

2. PD-L1 Antibody Reagents and Detection Kits

3. Clinical Trials for Colorectal Cancer-Related Gene Methylation Detection Kits

4. Clinical Evaluation of Pharmacogenomics-Related Gene Detection Reagents

link

Notice of the Centre for Medical Devices of the National Medical Products Administration on Issuing Three Guidance Principles Including the Registration Review Guidance Principle for Carbon Dioxide Laser Therapy Devices (No. 28 of 2025)

Abstract:

1. Carbon Dioxide Laser Therapy Devices

2. High-Frequency Surgical Instruments for Flexible Endoscopes

3. Ophthalmic Ultrasonic Phacoemulsification and Vitrectomy Devices and Accessories   

link

NIFDC

Notice Regarding the Call for Collaborative Standardisation Units for Lung Cancer Organoid Reference Samples  

link

Notice Regarding the Convening of the Second Session of the 2025 Physical Therapy Equipment Standards Implementation Conference

Abstract:

1. Discussion on standards pertaining to physical therapy products based on thermal conduction methods

2. YY/T 1975-2025 Far-infrared Magnetic Therapy Patches (Pouches)

link

Circular Regarding the Solicitation of Drafting Units for the National Standard Project: ‘Acceptance and Commissioning Guidelines for Medical Light Ion Beam Radiotherapy Planning Systems’

link

Forwarding Notice Regarding Convening the 2025 Second-Half Standards Implementation Meeting of the Disinfection Technical Committee

Abstract:

GB/T 18282.1-2025 Sterilisation of healthcare products – Chemical indicators – Part 1: General requirements

GB/T 24628-2025 Sterilisation of healthcare products – Biological and chemical indicators – Test equipment

GB/T 35267.4-2025 Washer-Disinfectors — Part 4: Endoscope Washer-Disinfectors

GB/T 45351-2025 Production of Cell-Based Medical Devices — Microbial Risk Control During Processing

GB/T 19973.2-2025 Sterilisation of Medical Products - Microbiological Methods - Part 2: Sterility Tests for Definition, Validation and Maintenance of Sterilisation Processes

YY/T 1957-2025 Negative Pressure Washer-Disinfectors

YY/T 0679-2025 Steam Formaldehyde Sterilisers

link

Forwarding the Notice from the Subcommittee on Active Implants of the National Technical Committee for Standardisation of Surgical Implants and Orthopaedic Devices Regarding the Solicitation of Drafting and Verification Units for One Recommended National Standard Plan

Abstract:

Cardiac Pacemakers — Small-Cross-Section Connectors for Implantable Cardiac Pacemakers

link

Forwarding Notice Regarding the Convening of the 2025 Medical Device Standards Implementation Training Session

Abstract:

YY/T 1959—2025 Specific Technical Requirements for Intraoral Digital X-ray Imaging Systems

GB/T 19042.2—2025 Evaluation and Routine Tests for Medical Imaging Departments — Part 3-2: Acceptance Tests for Imaging Performance of Mammography X-ray Equipment

YY/T 0310—2025 General Technical Requirements for X-ray Computed Tomography Equipment

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

link

FDA

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

link

MDR

Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles

link

Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746

link

Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices

link