On 10.03.2020, the NMPA published (No.18-2020) the essential principles of safety and performance of medical devices.
The principles describe the fundamental design and manufacturing requirements for the registrant / NMPA legal agent to ensure the medical device operates safely and performs as intended throughout its product life cycle under the control of a quality management system.
The essential design and manufacturing principles apply to medical devices in different aspects as below:
– Chemical, Physical, and Biological Properties
– Sterilization and Microbial Contamination
– Consideration of Environment and Conditions of Use
– Protection against Electrical, Mechanical, and Thermal Risks
– Active Medical devices and IVD Medical Devices and Medical Devices Connected to Them
– Medical Devices that Incorporate Software or are Software as Medical Device
– Medical Device with a Diagnostic or Measuring Function
– IFU and Labeling
– Protection against Radiation and Other Risks
– Medical Devices Incorporating Pharmceutical Ingredients
– Particular Requirements for Implantable Medical Devices
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