Guidance for the Review of Changes in Raw Materials of
Non-active Medical Devices
In order to further improve the quality of the medical devices, the licensees usually need to make changes in the manufacturing equipment, raw materials, manufacturing process, inspection method and quality control standards of the products after the approval for marketing. The establishment of an effective change control procedure by the licensee is the key to ensuring continuous improvement of the manufacture management system to achieve high quality products, which is also an important link in the quality management system for medical devices. According to the requirements of quality management system, the licensee shall fully evaluate the impact of the changes on the final medical device product and implement effective change control to reduce the risk caused by the changes to an acceptable level.
In general, the change control procedures include the proposal, analysis, review, verification, validation, approval and implementation of the change. Among them, analysis, verification, and validation according to different changes are the key works to be completed by the company, as well as the focus of the technical review for change items requiring review and approval.