The safety review of traditional Chinese medical devices certified by NMPA in China follows specific standards and procedures to ensure their safety and efficacy. Here are the key aspects:
Classification: Traditional Chinese medical devices are classified by NMPA based on risk levels, similar to other medical devices. The classification determines the level of scrutiny and requirements for certification.
Technical Documentation: Manufacturers must prepare comprehensive technical documentation that includes detailed descriptions of the device, its materials, manufacturing processes, and safety and efficacy data.
Testing and Evaluation: Depending on the device classification, testing and evaluation may be required to demonstrate safety, efficacy, and compliance with relevant Chinese standards and regulations. This may include laboratory testing, clinical evaluations, and literature reviews.
Expert Review: NMPA may convene expert panels or committees to review the technical documentation, test results, and overall safety profile of the traditional Chinese medical device. These experts assess whether the device meets the required safety and efficacy standards.
Quality Management System: Manufacturers must implement and maintain a quality management system (QMS) that complies with NMPA regulations. This ensures consistent production of safe and effective devices and facilitates ongoing compliance monitoring.
Post-Market Surveillance: Once certified, manufacturers are required to monitor the performance and safety of their devices in the market through post-market surveillance activities. This includes reporting adverse events and taking corrective actions as necessary.
Documentation and Reporting: Throughout the certification process and post-market phase, manufacturers must maintain accurate documentation and submit reports to NMPA as required by regulations. This ensures transparency and compliance with regulatory requirements.
By following these standards and procedures, manufacturers of traditional Chinese medical devices can ensure their products meet the rigorous safety and efficacy standards set by NMPA, thereby securing certification for import and sale in China's market.
.png)
.jpg "1 - 副本(2).jpg")
