The National Medical Products Administration proposes to revise 85 medical device industry standards.
The notice was issued by the State Administration of Medical Equipment of the Public Security Bureau to announce the plan of revising and standardizing the standards for the medical equipment industry in 2025, and 79 standards were included in the mandatory standards revision project, and 6 standards were included in the recommended standards revision project.
According to the notice, among the six standards included in the 2025 mandatory industry standards formulation and revision plan for medical devices, "General Technical Requirements for Thermal Conduction Physiotherapy Equipment" is a new standard to be established, while the other five are revisions, such as "Anesthesia and Respiratory Equipment - Manual Resuscitators," "Intravascular Catheters - Single-use Sterile Catheters Part 4: Balloon Dilatation Catheters," and "Laser Therapy Equipment - Holmium Yttrium Aluminum Garnet Laser Therapy Machines." The units responsible for the formulation and revision of these six standards are the Shanghai Institute of Medical Device Inspection and Research, Tianjin Medical Device Quality Supervision and Inspection Center, and Shandong Institute of Medical Devices and Drug Packaging Inspection, among others.
Among the 79 recommended industry standards for medical devices included in the 2025 revision and development plan, 54 are new developments, such as "General Rules for Degradation Test Methods of Recombinant Collagen Protein," "Performance Testing Methods for Artificial Intelligence Medical Devices - CT Image Analysis Software for Bone Fracture Assistance," and "Requirements and Test Methods for Puncture Surgery Navigation Equipment Using Robotic Technology." Twenty-five are revisions, including "Performance and Test Methods for Radiotherapy Planning Systems of Automatic Control Proximity Treatment Afterloading Equipment," "Fully Automatic Urine Sediment Analyzer," and "Tubal Cannula." The organizations tasked with developing and revising these 79 standards include the China National Institute for Food and Drug Control, Liaoning Provincial Institute for Medical Device Inspection and Testing, Guangdong Provincial Institutes for Product Quality Supervision and Inspection of Medical Devices, among others.
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