Medical device re-evaluation of how to start, what is his impact on the production enterprises

Medical device re-evaluation refers to the process of re-evaluating the safety and effectiveness of medical devices that have been registered or filed and marketed for sale, and taking corresponding measures. Adverse event monitoring and re-evaluation of medical devices is an important part of the implementation of post-market supervision of medical devices, is to strengthen the scientific supervision of the whole life cycle of medical devices, to improve the effectiveness of the supervision of an important initiative.

In recent years, the on-site verification of medical device production quality management standard has found that enterprises generally have poor awareness of adverse event monitoring and re-evaluation, unclear responsibility, inadequate system, incomplete records and other issues. How to implement medical device adverse event monitoring and re-evaluation in the medical device production quality system, to ensure the safety and effectiveness of the products after listing, is the work of the regulatory authorities need to think and promote. Re-evaluation of medical devices is an important input to the quality management system of medical device production, a key means to monitor the safety and effectiveness of medical device products after listing, and the core content of the whole life cycle management of medical devices. Effective monitoring and re-evaluation of adverse events, timely corrective and preventive measures, and continuous improvement of the system can effectively reduce the risk of medical device safety, improve the effectiveness, and promote medical device innovation and industrial development.