NMPA Essential Principles of Safety and Performance of Medical Devices

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 DevicesIf this information is relevant to you, feel free to contact us for more information.