{"id":"F2026L00225","name":"Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026","slug":"therapeutic-goods-medical-devices-foreign-countries-determination-2026","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":443177,"registerId":"F2026L00225-fast-fetch-1775958085791","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\n---\n\n![Commonwealth Coat of Arms of Australia](image.001.jpeg)\n\n \n\nTherapeutic Goods (Medical Devices—Foreign Countries) Determination 2026\n\nI, Marcelle Noja, as delegate of the Secretary of the Department of Health, Disability and Ageing, make the following determination.\n\nDated 6 March 2026\n\nMarcelle Noja\n\nAssistant Secretary  Medical Devices and Product Quality Division  Health Products Regulation Group  Department of Health, Disability and Ageing\n\n \n\n \n\n \n\n \n\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Medical devices—foreign countries and specified devices\n\nSchedule 1—Foreign countries\n\nSchedule 2—Specified medical devices\n\n \n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026.\n\n2  Commencement\n\n (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.\n\n \n\n- Commencement information\n- Column 1 Column 2 Column 3\n- Provisions Commencement Date/Details\n- 1. The whole of this instrument The day after this instrument is registered.\n\n\nNote: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.\n\n (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.\n\n3  Authority\n\n  This instrument is made under subsections 41HD(5) and 41HD(6) of the Therapeutic Goods Act 1989.\n\n4  Definitions\n\nNote: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n(a) medical device.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\n5  Medical devices—foreign countries and specified devices\n\n (1) The countries specified in Schedule 1 are foreign countries for the purposes of subparagraph 41HD(1)(d)(i) of the Act.\n\n (2) The medical devices specified in Schedule 2 are medical devices that can be the subject of an approval under section 41HD of the Act.\n\n\n\n\nSchedule 1—Foreign countries\n\nNote: See subsection 5(1).\n\n- Foreign countries\n- Column 1 Column 2\n- Item Countries\n- 1 Brazil\n- 2 Canada\n- 3 China (the People’s Republic of)\n- 4 Japan\n- 5 Member states of the European Union\n- 6 Singapore\n- 7 United Kingdom of Great Britain and Northern Ireland\n- 8 United States of America\n\n\n\n\n\nSchedule 2—Specified medical devices\n\nNote: See subsection 5(2).\n\n- Specified medical devices\n- Column 1 Column 2\n- Item Medical devices\n- 1 cannulas for use in cardiac surgery or cardiopulmonary bypass procedures\n\n\n \n","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":1,"scope_assessment":{"changed":false,"description":"This determination simply updates the list of recognised foreign countries and specifies which medical devices are covered, operating within the existing framework of section 41HD of the Therapeutic Goods Act 1989. It does not expand or alter the original purpose of the provision."},"complexity_factors":["Very short document with only 5 sections and 2 schedules","Minimal defined terms (only 'Act')","No cross-references or conditional logic","Clear and direct language"],"plain_english_summary":"This legal instrument lists eight countries (Brazil, Canada, China, Japan, European Union member states, Singapore, United Kingdom, and United States) whose approval of certain medical devices can be recognised in Australia. It also specifies that only cannulas used in heart surgery or heart-lung bypass procedures are eligible for this recognition. This means manufacturers of those devices can rely on overseas approvals instead of going through a separate full Australian assessment, reducing red tape and duplication. The instrument does not create new obligations but streamlines approval pathways for a narrow category of devices."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This instrument appears to serve its original narrow purpose: specifying foreign countries and device types for the section 41HD approval pathway. It has not expanded beyond this specific administrative function."},"complexity_factors":["Very short instrument (approximately 1.5 pages of substantive content)","Only 2 defined terms ('Act' and reference to 'medical device' from parent Act)","Simple structure: 5 operative sections plus 2 schedules","No nested exceptions, conditional logic, or cross-references beyond basic references to the parent Act (Therapeutic Goods Act 1989)","Schedules contain simple tabular lists (8 countries, 1 device type) with no sub-conditions","Operative provisions are straightforward declarations without temporal limitations, sunset clauses, or administrative procedures"],"plain_english_summary":"This is a short legal instrument that lists which foreign countries Australia recognises as having trustworthy medical device regulations, and which specific medical devices can be imported under a special approval scheme.\n\n**What it does:**\n- **Schedule 1** names 8 countries/regions (Brazil, Canada, China, Japan, EU member states, Singapore, UK, and USA) as approved foreign jurisdictions. This matters because Australian law allows certain medical devices to be approved for use here if they are already approved in these trusted overseas markets.\n- **Schedule 2** specifies one type of device that can be approved this way: **cannulas** (thin tubes) used in heart surgery or cardiopulmonary bypass procedures.\n\n**Who it affects:**\n- Medical device manufacturers and suppliers who want to bring heart surgery cannulas into Australia using the \"foreign country approval pathway\" (a faster route to market if the device is already approved overseas).\n- Patients and surgeons who use these specific cardiac devices.\n\n**Why it matters:**\nThis determination acts as a gatekeeper. Only devices from the listed countries can use this shortcut approval process, and currently only one specific device type (cardiac cannulas) is eligible. It helps ensure devices meet safety standards while streamlining import for critical surgical equipment."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-medical-devices-foreign-countries-determination-2026","history":"/api/acts/therapeutic-goods-medical-devices-foreign-countries-determination-2026/history","analysis":"/api/acts/therapeutic-goods-medical-devices-foreign-countries-determination-2026/analysis","conflicts":"/api/acts/therapeutic-goods-medical-devices-foreign-countries-determination-2026/conflicts","importantCases":"/api/acts/therapeutic-goods-medical-devices-foreign-countries-determination-2026/important-cases","documents":"/api/acts/therapeutic-goods-medical-devices-foreign-countries-determination-2026/documents"}}