The administrative counterparts should perform quality control on raw materials and ensure compliance with the requirements of relevant standards for the materials. And they should also conduct studies on the mechanical properties of the main raw materials, and provide data proving that the raw materials selected can meet the needs of now control stability of products. For example, for components that provide mechanical power, study should be conducted on the elastic modulus, hardness, and deformation of the raw materials, and the control criteria and verification reports for the raw materials should be submitted. For the material of the flow-limiting device, it should be stated whether the hardness, elasticity and other characteristics of the material will affect the flow accuracy under the intended use environment (temperature, humidity, atmospheric pressure), and relevant research data should be provided.
For the raw material pellets developed and produced by the administrative counterpart, the administrative counterpart should provide a detailed formulation development report, including a verification report proving compliance with the requirements of relevant standards for the raw materials. If the administrative counterpart of the device is using outsourced pellets, the supplier should be required to submit a verification report proving that the raw materials meet the relevant standards for the raw materials or the supporting evaluation data proving the suitability for the intended medical use of the product under application.
For new materials used in medical devices for the first time, relevant research data should be provided proving the material’s suitability for the intended site in the human body.
