Biomaterial Database

The Australian Medical Device Vigilance System. 1996

D R Beech

Therapeutic Devices Branch, Therapeutic Goods Administration, Woden, Australia.

Since its inception, in 1986, the Australian Vigilance System has had voluntary and compulsory components. The voluntary component is the Therapeutic Device Problem Reporting Scheme and the compulsory one is requirements on sponsors to report as a condition of entry on the Australian Register of Therapeutic Goods. In addition, reports produced worldwide are actively monitored for their applicability to Australia.

UI	MeSH Term	Description	Entries
D011358	Product Surveillance, Postmarketing	Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.	Drug Surveillance, Postmarketing,Evaluation Studies, Postmarketing,Postmarketing Product Surveillance,Product Surveillance, Post-Marketing,Drug Surveillances, Postmarketing,Evaluation Study, Postmarketing,Post-Marketing Product Surveillance,Post-Marketing Product Surveillances,Postmarketing Drug Surveillance,Postmarketing Drug Surveillances,Postmarketing Evaluation Studies,Postmarketing Evaluation Study,Postmarketing Product Surveillances,Product Surveillance, Post Marketing,Product Surveillances, Post-Marketing,Product Surveillances, Postmarketing,Studies, Postmarketing Evaluation,Study, Postmarketing Evaluation,Surveillance, Post-Marketing Product,Surveillance, Postmarketing Drug,Surveillance, Postmarketing Product,Surveillances, Post-Marketing Product,Surveillances, Postmarketing Drug,Surveillances, Postmarketing Product
D004864	Equipment and Supplies	Expendable and nonexpendable equipment, supplies, apparatus, and instruments that are used in diagnostic, surgical, therapeutic, scientific, and experimental procedures.	Apparatus and Instruments,Devices,Medical Devices,Device, Medical,Devices, Medical,Equipment,Inventories,Medical Device,Supplies,Device,Instruments and Apparatus,Inventory,Supplies and Equipment
D004869	Equipment Safety	Freedom of equipment from actual or potential hazards.	Device Safety,Hazards, Equipment,Medical Device Safety,Safety, Equipment,Device Safety, Medical,Safety, Medical Device,Equipment Hazard,Equipment Hazards,Hazard, Equipment,Safety, Device
D005062	European Union	An economic union with the principal objectives of free movement of goods, capital, and labor. The constituent countries are Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden. (https://europa.eu/european-union/about-eu/countries accessed 12/31/2020)	Common Market,Euratom,European Atomic Energy Community,European Coal and Steel Community,European Common Market,European Community,European Economic Community,Community, European Economic,EEC,Economic Community, European,Common Market, European,Common Markets,Common Markets, European,Communities, European,Communities, European Economic,Community, European,Economic Communities, European,European Common Markets,European Communities,European Economic Communities,Market, Common,Market, European Common,Union, European
D001315	Australia	The smallest continent and an independent country, comprising six states and two territories. Its capital is Canberra.	Canton and Enderbury Islands,Christmas Island,Christmas Island (Australia)
D017408	Guidelines as Topic	Works about a systematic statement of policy rules or principles. Guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by convening expert panels. For guidelines in the field of health care and clinical medicine, PRACTICE GUIDELINES AS TOPIC is available.	Guidelines as Topics