For High-risk Medical Devices Using Polymer Materials, Are Two Or More Raw Material Suppliers Allowed For The Raw Materials Of Product Parts?

For high-risk medical devices using polymer materials, the suppliers of the raw materials of products should be specified in the registration application dossiers. If there are two or more raw materials suppliers for the same raw material, the administrative counterpart should separately conduct design verification and validation of products made from raw materials of different sources to ensure that products made from raw materials of all sources are safe and effective as required. At the same time, the administrative counterpart should conduct separate procurement control of the raw materials provided by each supplier (the registration application dossiers generally include the quality agreement between the raw material supplier and the product manufacturer, the quality control criteria for the raw material, the raw material inspection report, and the qualification certificate of the raw material supplier, etc.).