Thursday, 29 February 2024 / Published in Medical Device, News, NMPA Registration in China

China medical device industry standards: Newly released and revised standards in February 2024 for implementation

China medical device industry standards have seen 9 new additions and 11 revisions announced by the China NMPA (National Medical Products Administration) on February 19, 2024.

New YY standards implemented

8 new industry standards will come into effect for implementation from March 1, 2025, onwards:

In addition to the above standards, YY/T 1766.4—2024 Image quality evaluation methods for computed tomography system—Part 4: Imaging performance under automatic exposure control is a new standard that will come into effect on September 1, 2025.

Revised YY standards for implementation

10 revised industry standards will come into effect on March 1, 2025:

Coming into effect on March 1, 2026, YY 1001-2024 standard for glass syringes is a revised industry standard to replace both YY 1001.1-2004 “Glass syringes – Part 1: Syringes with all-glass” and YY 1001.2-2004 “Glass syringes. Part 2: Blue syringes with all-glass”.

Highlights standards

While each standard addresses specific medical device products, they collectively emphasize requirements for performance, testing, labeling, and safety measures. Here is a summary of what the newly introduced standards addresses as tailored to specific medical applications and technologies:

Medical Inductively Coupled Plasma Mass Spectrometer (ICP-MS): The respective YY standard specifies the requirements, labeling, instructions for use, packaging, transportation, and storage. The standard applies to indication of use for primarily analyzing inorganic elements in human samples.
X-ray Computed Tomography (CT) Scanning Equipment: The standard describes imaging performance evaluation methods, especially when using automatic exposure control technology.
BCR-ABL Fusion Gene Test Kit: The respective standard covers requirements for labeling, instructions for use, packaging, transportation, and storage for test kits intended to detect BCR-ABL fusion genes in blood and bone marrow samples.
Hydrophilic Lubricant Coated Medical Catheters/Guidewires: The standard specifies coating adhesion test methods for vascular catheters and guidewires with hydrophilic lubricant coatings.
Medical Plasma Freezer: The standard classifies products and outlines corresponding test methods for medical plasma freezers using specific cooling methods.
Single-Photon Emission Computed Tomography (SPECT) Systems for Cardiac Imaging: The respective standard defines the performance and testing methods for SPECT systems used solely for cardiac imaging or with specialized cardiac imaging subsystems.
Neurovascular Thrombectomy Stent: The industry standard covers general requirements of the expected performance, design attributes, materials, lab design evaluation, post-market surveillance, manufacturing, sterilization, and packaging.
Orthopedic Implant Bandage Fixation Plate: The industry standard specifies performance requirements and testing methods for evaluating fixation plates for connecting soft tissue to bone or bone to bone.
Breast Biopsy and Cutting Equipment: The respective standard defines terminology, materials, requirements, and corresponding test methods for breast biopsy and cutting equipment.

Further information

Read the original NMPA announcement on the 20 industry standard updates in China.

Adhering to these standards is crucial for businesses seeking to sell medical device products in China, as compliance ensures both product safety and market access. Non-compliance can result in regulatory hurdles, delays in market entry, and even market withdrawal, significantly impacting business operations and market competitiveness.

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