China's 2025 Medical Device Industry Standard Formulation and Revision Plan Announced

China’s 2025 Medical Device Industry Standard Formulation and Revision Plan has been announced by the National Medical Products Administration (NMPA). This plan sets out NMPA's 2025 medical device industry standard formulation and revision intentions, introducing 85 new standards, including 6 mandatory updates and 79 recommended guidelines.

These changes target critical areas like anesthesia, extracorporeal bypass, vascular intervention, artificial intelligence in diagnostics, and additive manufacturing, ensuring greater safety, effectiveness, and global alignment with ISO standards. More detail about the NMPA plan follows below

Mandatory standard update: strengthen regulatory requirements in six areas

According to the announcement, the six mandatory standards to be revised or formulated in 2025 involve key areas such as anesthesia, extracorporeal bypass, and vascular intervention, which are directly related to product market access and compliance. Overseas manufacturers need to focus on the following:

The name of the medical deviceStandard statusOriginal standardThe current standardFocus of updateAnesthesia and respiratory equipment – artificial resuscitatorsrevisionYY 0600.4 - 2013ISO 10651 - 4:2023 is adoptedEnhance the performance requirements and test methods of resuscitators and enhance harmonization with ISO standardsGeneral technical requirements for thermally conductive physiotherapy equipmentformulate/First releaseClarify the thermal conduction efficiency, safety limits and clinical applicability requirements of the equipmentIntravascular Catheters – Single-Use Sterile Catheters (Part 4: Balloon Dilation Catheters)revisionYY 0285.4 - 2017Adopt ISO 10555 - 4:2023Optimize the material biocompatibility and burst pressure test standards of balloon cathetersLaser treatment equipment - holmium-doped yttrium aluminum garnet laser treatment machinerevisionYY 0846 - 2011None (revision of the original standard)Refine the stability of laser output and the safety specifications of clinical operationCardiopulmonary drainage system – extracorporeal bypass ductsrevisionYY 1048 - 2016None (revision of the original standard)Improve the pressure resistance and biological safety of pipe materialsCardiopulmonary Circulation System – Blood Gas Exchanger (Oxygenator)revisionYY 0604 - 2016ISO 7199:2024 is adoptedInternational standards were introduced to optimize the evaluation methods of oxygenation efficiency and hemocompatibility

• Urgency of implementation: The above-mentioned mandatory standards are expected to come into effect in 2025, and relevant enterprises need to carry out technical adaptation and compliance verification in advance to avoid delays in market access.

Overview of the recommended standard classification: full coverage of technological innovation and subdivisions

There are a total of 79 recommended standards, covering cutting-edge fields such as artificial intelligence, in vitro diagnostics, additive manufacturing, and biological evaluation, providing technical reference and innovation guidance for the industry. The main classifications are as follows (click here for a complete list):

Category Standard project name Revision/Formulate Revised standard number The international standard number used In vitro diagnostics Mycoplasma pneumoniae nucleic acid detection kit formulate / / Hepatitis C virus nucleic acid detection kit formulate / / Cystatin C Assay Kit revision YY/T 1230—2014 / Medical device materials and test methods General Principles of Recombinant Collagen Degradation Test Methods formulate / / Medical Device Hemolysis Test Part 2: Mechanical Force-Mediated Hemolysis Test formulate / / Medical equipment Automated brachytherapy afterloading equipment, radiotherapy planning system performance and test methods revision YY/T 0973—2016 / Anesthesia and Respiratory Equipment Anesthesia air reservoir revision YY/T 0978—2016 ISO 5362:2024 Intravascular catheters Single-use sterile catheters Part 1: General requirements revision YY 0285.1—2017 ISO 10555-1:2023 Surgical and implantable devices Surgical Instruments Tubular staplers and components revision YY/T 0245—2008 / Medical Needle Injection System Requirements and Test Methods Part 1: Needle Injection System revision YY/T 1786.1—2021 ISO 11608-1:2022 General requirements for non-passive surgical implant coupled devices revision YY/T 0726—2020 ISO 16061:2021 Traditional Chinese Medicine and Dental Instruments TCM Apparatus Skin Acupuncture Part 2: Rolling Style formulate / ISO 23958-2:2022 Dentistry Root Canal Instruments Part 2: Enlarged Drill revision YY/T 0803.2—2020 ISO 3630-2:2023 Dentistry Root canal filling materials revision YY/T 0495—2009 ISO 6877:2021 Evaluation and analysis of medical devices Artificial Intelligence Medical Devices Fracture CT Image Assisted Analysis Software Algorithm Performance Test Method formulate / / Requirements and test methods for navigation equipment for puncture surgery using robotic technology formulate / / Real-world data collection requirements for medical devices formulate / / Medical device packaging Test Methods for Packaging of Sterile Medical Devices Part XX: Detection of Packaging Leaks by High Voltage Discharge Method formulate / /

Impact on overseas manufacturers

Key challenges:

• Technical adaptation: Some standards adopt the new version of ISO requirements, and enterprises need to re-verify product performance.
• Compliance: After the implementation of mandatory standards, products that do not pass the certification will not be able to enter the Chinese market.

Solution:

• Plan ahead: It is recommended that enterprises immediately start standard difference analysis to optimize the design and testing process.
• Cooperation with Cisema: Through cooperation with professional service providers such as Cisema, we can efficiently complete compliance declarations and technical document preparation. Cisema provides the following support:
  • 1. Standard interpretation and gap analysis: Provide customized compliance roadmap for these 85 standards.
  • 2. Testing and reporting services: Joint CNAS accredited laboratories to accelerate the product validation and registration process. 3.
  • 3. Ongoing tracking services: Real-time updates on regulatory developments to ensure long-term corporate compliance.

Further Information

To read the original NMPA unveiled its 2025 medical device industry standard formulation and revision plan, please click here. If you have specific questions about how NMPA's Medical Device Industry Standard Formulation and Revision Plan may affect you, please contact Cisema.

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