《heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管课件.pptx》由会员分享，可在线阅读，更多相关《heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管课件.pptx（18页珍藏版）》请在三一文库上搜索。
1、The regulation of medical devices in Australia,heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管,Overview,Comparing 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 approach,2,Risk c
2、lassification rulesIn vitro diagnostic testsEssential principlesConformity assessmentSafety and performanceOther education modules,heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管,Comparing medicines and medical devices,3,heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管,What is a medical device?
3、,4,The 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
4、 physiological processcontrol of conception,heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管,Many patients require medical devices,5,Tens of thousands of hip and knee procedures are performed every year. Ongoing safety and performance monitoring is important to ensure public safety after the devic
5、e is made available on the market.,5,heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管,How does a medical device get to market?,6,Medical devices can not be tested like medicines in a traditional clinical trialInformation on their performance and safety is important prior to market authorisationMos
6、t new devices are improvements of older versions based on data collected from real life use,*More information about what this means is provided later in the presentation,heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管,Benefit versus risk approach,7,A device may be selected for review by the TGA o
7、nce it is on the market. More information and case studies are in the educational module on postmarket monitoring.,The level of regulation is based on consideration of:,7,heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管,Risk classification rules medical devices,8,heregulationofmedicaldevicesinAust
8、ralia澳大利亚市医疗器械监管,In vitro diagnostics have been regulated since July 2010 with a four year transition period. By the end of the transition period (2014) all IVDs will be regulated to protect public and personal health,In vitro diagnostic tests,9,Examples of IVDs,heregulationofmedicaldevicesinAustral
9、ia澳大利亚市医疗器械监管,10,Risk classification rules - IVDs,heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管,Essential principles that govern devices,11,See the following slide for an example,heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管,Assessing benefits versus known side effects,12,Left ventricular
10、assist device,heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管,Essential principles that govern devices,13,See the following slide for an example,heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管,Devices and energy sources,14,ECG patient monitor,heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管,
11、Conformity assessment,15,Conformity assessments are all about the manufacturer!They are used to ensure the essential principles and other regulatory requirements are met. The procedure for demonstrating this varies depending on the classification of the device. Generally, the conformity assessment p
12、rocedure is more rigorous the higher the risk class,heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管,Safety and performance ongoing activities,16,heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管,More information,17,We have systems in place that provide access to unapproved medical devices. For e
13、xample, under the Special Access Scheme an unapproved device can be obtained for a single patient on a case-by-case basis. Further information is in the medicines educational moduleWe have created a separate educational module on postmarket monitoring which details what we do once the products are i
14、n the supply chain. This is an integral part of the regulatory systemThe module covers more of the: inclusion process our vigilance and compliance programs,There are also five other modules in this suite of educational materials. These can be accessed by the links on the next slide.,17,heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管,Other education modules include:,18,Introduction to the TGA,Medicines,Biologicals,Postmarket monitoring,Good Manufacturing Practice,heregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管,