TheregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管.pptxVIP

TheregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管第1页/共19页 OverviewComparing medicines and medical devicesWhat is a medical device?Statistics on patients requiring medical devicesHow does a medical device get to market?The benefit versus risk approach2Risk classification rulesIn vitro diagnostic testsEssential principlesConformity assessmentSafety and performanceOther education modules第2页/共19页 Comparing medicines and medical devices3A medical device does not achieve its principal intended action by pharmacological, immunological or metabolic means like a medicine or vaccine第3页/共19页 What is a medical device?4The TGA defines a medical device as an instrument apparatus, appliance, material or other article intended to be used for human beings for: diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or disabilityinvestigation, replacement or modification of the anatomy or of a physiological processcontrol of conceptionBandagesDental implantBreast implantGlucose monitor第4页/共19页 Many patients require medical devices5Tens of thousands of hip and knee procedures are performed every year. Ongoing safety and performance monitoring is important to ensure public safety after the device is made available on the market.5第5页/共19页 How does a medical device get to market?6Medical devices can not be tested like medicines in a traditional clinical trialInformation on their performance and safety is important prior to market authorisationMost new devices are improvements of older versions based on data collected from real life useA sponsor makes an application to include a device on the Australian Register of Therapeutic Goods (ARTG) so that it can be legally supplied in AustraliaThe applicant must have information available to demonstrate the quality, safety and performance of the medical device The device must undergo a Conformity Assessment* procedure and comply with the Essential Principles*. *More information about what this means is provided later i