The NMPA issued the "list of mandatory standards applicable to medical devices" on November 11, 2022, directing manufacturers for China type testing and regulatory submissions. Over 400 mandatory national and industry standards are included.
China Mandatory standards are legally binding. Decree 739, Regulation on Supervision and Management of Medical Devices, the highest law governing medical device industry in China, mandates that "medical device shall meet the national mandatory standards; if there are no national mandatory standards, they shall comply with the industry mandatory standards".
The Device List
The list of devices is categorized based on NMPA Medical Device Classification Catalog. Please note that multiple mandatory national and industry standards may apply to each device.
The devices include but not limited to the following:
- Laser Surgery Devices
- High-Frequency Surgical Devices
- Radio Frequency Ablation Devices
- Argon Protective Coagulation Devices
- Perfusion Pumps for RF Ablation Devices
- Electric Stapler
- Stapler (with nails)
- Stapler (without nails)
- Medical Electron Accelerator
- Medical Light Ion Therapy System
- Medical X-ray Treatment Devices
- Gamma Beam Teletherapy Machine
- Close-up Rear Treatment Devices
- Radiation Therapy Simulation System
- X-ray Image Guidance System for Radiation Therapy
- Radiation Therapy Stereotactic System
- Contrast X-ray Machine
- … …
NMPA Mandatory Standards
16 general mandatory standards specify requirements for medical electrical systems, diagnostic X-ray devices, passive surgical implants, bone joints and spinal implants are also released. We listed a few for your reference：
- Safety requirements for electrical device for measurement, control and laboratory use Part 4: Special requirements for sterilizers and washer-disinfectors for handling medical materials
- Medical electrical device Part 1: General requirements for basic safety and essential performance
- Medical electrical device Part 1-2: General requirements for basic safety and essential performance Parallel standard: electromagnetic compatibility Requirements and tests
- Medical Electrical Device Part 1-11: General Requirements for Basic Safety and Essential Performance Tied Standard: Requirements for Medical Electrical Device and Medical Electrical Systems Used in Home Care Environments
- Medical electrical Device Part 1-3: General requirements for basic safety and basic performance Parallel standard: radiation protection for diagnostic X-ray device
- Passive surgical implants Bone joint and spinal implants Part 1: Special requirements for bone joint implants
- Passive surgical implants Bone joints and spinal implants Part 2: Special requirements for spinal implants
If your product is impacted by the standards status change, please email me. I am interested to learn about your experience.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------