For Implantable Drug-supplying Device With Coatings What Kind Of Performance Studies Should Be Carried Out?

If the implantable drug-supplying device has a coating, information on the chemical composition, purity and proportion of the coating should be provided. Relevant performance studies should be carried out, including qualitative and quantitative analysis (if applicable) of the coating, release performance (for the coating containing drugs)? use performance evaluation (such as lubricity of hydrophilic coating), shedding rate (if applicable), and safety evaluation documents etc. If the coating contains drugs, a safety and effectiveness study report on the drug added should also be provided, which should include at least: drug name, dosage; compatibility of the drug with the raw material used to make the device; the impact on human body caused by any changes of administration route, dosage, and drug storage conditions, etc. If the coating contains a biologically active substance, it is also necessary to provide the biosafety study data for the biologically active substance.