澳洲医疗器材登记法规问题集

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各国医疗器材登记法规问答集

时间：2023/08/24 drafted by Yvonne Chen

HLF-TW-10
请问澳洲对于医疗器材的归类方式为何？它的正式名称为何？不同归类管理强度有何差异?它的政府管辖机构为何？网页？

What are the categories of medical devices in Australia? What is its official name? What is the intensity of management of different categories? What is the governmental authority of medical devices? Website?
Evershine RD：
澳洲的医疗器材由治疗用品管理局 (TGA) 监管，负责评估和监控医疗器材。
医疗器材是指製造为单独或组合用于人类的任何仪器、装置、器具、机器、器具、植入物、体外试剂或校准器、软件、材料或其他类似或相关物品，用于以下一个或多个特定目的：
1.诊断、预防、监测、预测、预后、治疗或缓解疾病。
2.损伤的诊断、监测、治疗、减轻或补偿。
3.解剖结构或生理过程的调查、替换、修改或支持。
4.支持或维持生命。
5.通过对人体标本进行体外检查，为医疗或诊断目的提供资讯。该装置不能通过药理学、免疫学或代谢手段在人体内或人体上实现其主要预期作用，但可以通过这些手段辅助其达到预期功能。

医疗器材根据对人体的风险程度有不同的分类：
一、IVD 分类
1.第1级：无公共卫生风险或个人风险低。
2.第2级：低公共卫生风险或中等个人风险。
3.第3级：中等公共卫生风险或高个人风险。
4.第4级：高公共卫生风险。

二、医疗器材分类(非 IVD)

1. I类：风险等级低。
2. Is类(无菌)、Im类(具有测量功能)、IIa类 ：风险等级低到中。
3. IIb类：风险等级中到高。
4. III类：风险等级高。

Medical devices in Australia are regulated by the Therapeutic Goods Administration (TGA), which evaluates, and monitors medical devices.
Medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article manufactured for use in humans, alone or in combination, for one or more of the following a specific purpose:

1. Diagnosis, prevention, monitoring, prediction, prognosis, treatment or mitigation of disease.
2. Diagnosis, monitoring, treatment, mitigation or compensation of injury.
3. Investigation, replacement, modification, or support of anatomical structures or physiological processes.
4. To support or sustain life.
5. Providing information for medical or diagnostic purposes through in vitro examination of human specimens. The device cannot achieve its main expected function in or on the human body through pharmacological, immunological or metabolic means, but it can be assisted to achieve the expected function through these means.

There are different classifications of medical device according to the degree of risk to the human:

1. IVD Classification
2. Class 1: No public health risk or low personal risk.
3. Class 2: Low public health risk or moderate personal risk.
4. Class 3: Moderate public health risk or high personal risk.
5. Class 4: High public health risk.
6. Classification of medical devices (non-IVD)
7. Class I: low risk level.
8. Class Is (sterile), Class Im (with measuring function), Class IIa: the risk level is low to medium.
9. Class IIb: moderate to high risk.
10. Category III: high risk level.

【参考连结】
https://www.tga.gov.au/products/medical-devices/medical-devices-overview
https://www.tga.gov.au/resources/resource/guidance/classification-ivd-medical-devices/classifying-ivds
https://www.tga.gov.au/resources/what-classification-my-medical-device#node-554

HLF-TW-20
外国公司要到澳洲销售医疗器材，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

If a foreign company wants to sell medical devices in Australia, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
无营业特许证。
No business license.

【参考连结】
https://www.tga.gov.au/products/medical-devices

HLF-TW-25
假如需要办理，请问澳洲有专业服务公司可以协助办理医疗器材公司营业许可证？
Evershine RD：
无营业特许证。
No business license.

HLF-TW-30
外国公司要到澳洲销售医疗器材，可以指派澳洲公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

If a foreign company wants to sell medical devices in Australia, can it assign an Australia company to act as a business agent? What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
可以。营业代理人无特殊条件要求。

产品责任
1.当发生医疗器材不良事件，医疗器材的产品註册者(担保人)必须报告TGA(强制)，包含：初步报告、后续报告和最终报告。

2.供应商、批发商、分销商、进口商和製造商有责任监督医疗器材产品安全，当有发现产品安全问题时，必须向ACCC提出报告(强制)。

No business license.

Product liability

1. When a medical device adverse event occurs, the product registrant (guarantor) of the medical device must report TGA (mandatory), including: initial report, follow-up report and final report.
2. Suppliers, wholesalers, distributors, importers and manufacturers are responsible for supervising the safety of medical device products. When product safety problems are found, they must report to ACCC (mandatory).

【参考连结】
https://www.tga.gov.au/resources/resource/forms/report-medical-device-adverse-event-sponsormanufacturer
https://apps.tga.gov.au/prod/mdir/mdirsummary.aspx?sid=1427158301
https://www.accc.gov.au/business/selling-products-and-services/product-safety-responsibilities#toc-ensure-products-you-sell-are-safe
https://www.tga.gov.au/products/medical-devices

HLF-TW-35

HLF-TW-40
外国公司销售到澳洲医疗器材本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？

Do foreign companies need to apply for an approval before importing medical devices sold to Australia? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
需要，须以澳洲居民或澳洲的法人团体身分将产品註册在澳洲治疗产品登记册(ARTG) 中。

流程
1.註册TGA 商业服务帐号 (Client ID)
．担保人：担保人必须是澳洲居民或澳洲的法人团体并有在澳洲开展业务，且公司代表居住在澳洲。
．详细地址：街道、郊区/州、邮政编码、邮寄地址、公司联繫方式、账单详细讯息、电子邮件、电话、电子邮件。
．组织管理者：管理员全名(负责建立和维护组织的联繫)、电子邮件、电话。
．澳洲代表：必须保留至少一名澳洲代表，境外代理商请指定您所在组织的澳洲代表作为授权联繫人，需留存全名、电子邮件、电话。
．声明。
缴交：电子邮件交至 TGA TBS 服务台：ebs@health.gov.au

2.申请註册澳洲治疗产品登记册(ARTG)
缴交资料请以英语方式呈现。
网页：https://reurl.cc/qLxK7R
I 类非无菌、非测量和 1 类 IVD 医疗器材
．缴交製造商的符合性声明。
．产品资讯，包括：标籤、包装、宣传册、目录、使用说明等。
．製造商和 GMDN 代码(如果 GMDN 代码未出现在代码表中，请将详细资讯电子邮件发送至 devices@tga.gov.au)
．申请人认证、缴交申请费。

I 类医疗器材(仅出口)和 1 类 IVD 医疗器材(仅出口)
．缴交製造商的符合性声明。
．选择製造商并提供设备的出口名称。
．申请人认证、缴交申请费。

I 类非无菌、非测量医疗器材、1 类 IVD 医疗器材和 I 类医疗器材/仅限出口的 1 类 IVD 医疗器材之外的所有类别
．缴交製造商证据、选择 GMDN 代码。(如果 GMDN 代码未出现在代码表中，请将详细资讯电子邮件发送至 devices@tga.gov.au)
．缴交製造商的符合性声明。
．缴交产品资料副本：标籤、设备的图片、包装(设备的内包装和外包装) 、使用说明、产品手册、与设备相关的其他手册、医疗器材的广告材料，包括小册子、网页摘录和广告。
．保留作用机制和原理等资料，以证明产品是否符合医疗器材的定义。
．证明遵守基本原则的证据，对于高风险设备须要提供临床证据报告和/或风险管理报告。
．对于III 类医疗器材、AIMD 医疗器材和4 类IVD 医疗器材(属于免疫血液学试剂的4 类IVD 医疗器材除外)，请填写唯一产品标识符(UPI)、功能描述、涵盖的器材总数以及适用的变体类型和变体范围。
．海外监管机构/评估机构的市场授权证据。
．申请人认证、缴交申请费。

标籤
医疗器材的标籤可以用多种语言，但其中一种语言必须是英语，需要标註下列资料：
1.製造商名称或商业名称和地址。
2.设备的预期用途、设备的预期用户以及预期使用该设备的患者类型。
3.提供足够的资讯让用户能够辨识设备或包装内容(如果相关)。
4.适用于设备的任何特定处理方式或储存要求。
5.与设备使用相关的任何警告、限制或预防措施。
6.使用设备的任何特殊操作说明。
4.表明该设备仅供一次性使用(如果适用) 。
8.表明该设备是为特定个人或健康专业人员定制的，并且仅供该个人或健康专业人员使用(如果适用) 。
9.研究用医疗器材，在适用情况下，依分类标示：
．非IVD的医疗器材：该器材用于上市前临床研究。
．IVD的医疗器材：该设备仅用于性能评估。
10.无菌设备须标示STERILE一词以及有关用于对设备进行灭菌的方法的资讯。
11.设备的批次代码、批号或序列号。
12.以清楚的月份、年份方式标示设备可以的安全使用日期 (如果适用)
13.设备製造日期的声明(可能包含在设备的批次代码、批号或序列号中，前提是该日期是清晰可辨的)。
14.出口使用的器材，请註明仅供出口。
15.将医疗器材纳入澳洲治疗产品登记册 (ARTG) 的法律责任人在立法中被称为贊助者，标籤上应标示贊助者的姓名和地址。
16.如果在设备本身或设备使用的包装上无法提供这些详细资讯，则贊助商的名称和地址必须包含在设备随附的单张中。

If required, the product must be registered with the Australian Register of Therapeutic Goods (ARTG) as an Australian resident or an Australian body corporate.

Process

1. Register TGA business service account (Client ID)
   ．Guarantor: The guarantor must be an Australian resident or an Australian body corporate and have a business in Australia, and the company representative lives in Australia.
   ．Address Details: Street, Suburb/State, Zip Code, Postal Address, Business Contact, Billing Details, Email, Phone, Email.
   ．Organization Manager: Administrator’s full name (responsible for establishing and maintaining connections to the organization), email, phone.
   ．Australian representative: At least one Australian representative must be retained. For overseas agents, please designate the Australian representative of your organization as the authorized contact person. Full name, email, and phone number must be kept.
   ． statement.
   Submit: Email to TGA TBS Help Desk: ebs@health.gov.au
2. Apply for registration in the Australian Register of Therapeutic Goods (ARTG)
   Please submit the materials in English.
   URL: https://reurl.cc/qLxK7R
   Class I Non-Sterile, Non-Measurement, and Class 1 IVD Medical Devices
   ．Submit the manufacturer’s declaration of conformity.
   ．Product information, including: labels, packaging, brochures, catalogs, instructions for use, etc.
   ．Manufacturer and GMDN code (if the GMDN code does not appear in the code table please email details to devices@tga.gov.au)
   ．Applicant certification and payment of application fee.

Class I medical devices (export only) and Class 1 IVD medical devices (export only)
．Submit the manufacturer’s declaration of conformity.
．Select a Manufacturer and provide an export name for the device.
．Applicant certification and payment of application fee.

All categories except Class I non-sterile, non-measuring medical devices, Class 1 IVD medical devices, and Class I medical devices/Export-only Class 1 IVD medical devices
．Submit proof of manufacturer, select GMDN code. (If the GMDN code does not appear in the code table please email details to devices@tga.gov.au)
．Submit the manufacturer’s declaration of conformity.
．Submit copies of product literature: labels, pictures of the device, packaging (inner and outer packaging of the device), instructions for use, product manuals, other manuals related to the device, advertising materials for medical devices, including brochures, web page excerpts and advertisements .
．Information such as the mechanism of action and reasons are retained to prove whether the product meets the definition of a medical device.
．Evidence to demonstrate compliance with basic principles, for high-risk devices, clinical evidence reports and/or risk management reports are required.
．For Class III medical devices, AIMD medical devices, and Class 4 IVD medical devices (except Class 4 IVD medical devices that are immunohematology reagents), please complete the Unique Product Identifier (UPI), Functional Description, Total Devices Covered, and applicable Variant type and variant range.
．Evidence of market authorization from overseas regulators/assessment agencies.
．Applicant certification and payment of application fee.

Label
The labels of medical device can be in multiple languages, but one of the languages must be English, and the following information needs to be marked:

1. Manufacturer’s name or business name and address.
2. The intended use of the device, the intended user of the device, and the type of patients expected to use the device.
3. Provide enough information to allow the user to identify the device or package contents (if relevant).
4. Any specific handling or storage requirements applicable to the device.
5. Any warnings, restrictions, or precautions related to the use of the device.
6. Any special operating instructions for using the device.
7. Indicate that the device is intended for single use only (if applicable).
8. Indicates that the device is custom-made for a specific individual or health professional and is intended for use by that individual or health professional only, if applicable.
9. Medical devices for research, where applicable, marked according to classification:
   ． Non-IVD medical device: The device is used for pre-market clinical research.
   ． Medical Device for IVD: This device is for performance evaluation only.
10. Sterile device must be marked with the word STERILE and information about the method used to sterilize the device.
11. Batch code, lot number or serial number of the device.
12. Mark the safe use date of the device in a clear month and year (if applicable)
13. A statement of the date of manufacture of the device (may be included in the batch code, batch number or serial number of the device, provided the date is clearly identifiable).
14. For the device used for export, please indicate that it is only for export.
15. The person legally responsible for placing a medical device on the Australian Register of Therapeutic Goods (ARTG) is referred to in the legislation as the sponsor and the name and address of the sponsor shall appear on the label.
16. If these details cannot be given on the device itself or on the packaging used with the device, the sponsor’s name and address must be included on the leaflet accompanying the device.

【参考连结】
https://www.legislation.gov.au/Details/F2023C00565
https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/supply-medical-device/medical-device-inclusion-process
https://www.tga.gov.au/resources/resource/guidance/supporting-documentation-inclusion-medical-device

HLF-TW-45

HLF-TW-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？？网页？

Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：
不行，须以澳洲居民或澳洲的法人团体身分将产品註册在澳洲治疗产品登记册(ARTG) 中。

流程
1.註册TGA 商业服务帐号 (Client ID)
．担保人：担保人必须是澳洲居民或澳洲的法人团体并有在澳洲开展业务，且公司代表居住在澳洲。
．详细地址：街道、郊区/州、邮政编码、邮寄地址、公司联繫方式、账单详细讯息、电子邮件、电话、电子邮件。
．组织管理者：管理员全名(负责建立和维护组织的联繫)、电子邮件、电话。
．澳洲代表：必须保留至少一名澳洲代表，境外代理商请指定您所在组织的澳洲代表作为授权联繫人，需留存全名、电子邮件、电话。
．声明。
缴交：电子邮件交至 TGA TBS 服务台：ebs@health.gov.au

2.申请註册澳洲治疗产品登记册(ARTG)
缴交资料请以英语方式呈现。
网页：https://reurl.cc/qLxK7R
I 类非无菌、非测量和 1 类 IVD 医疗器材
．缴交製造商的符合性声明。
．产品资讯，包括：标籤、包装、宣传册、目录、使用说明等。
．製造商和 GMDN 代码(如果 GMDN 代码未出现在代码表中，请将详细资讯电子邮件发送至 devices@tga.gov.au)
．申请人认证、缴交申请费。

I 类医疗器材(仅出口)和 1 类 IVD 医疗器材(仅出口)
．缴交製造商的符合性声明。
．选择製造商并提供设备的出口名称。
．申请人认证、缴交申请费。

I 类非无菌、非测量医疗器材、1 类 IVD 医疗器材和 I 类医疗器材/仅限出口的 1 类 IVD 医疗器材之外的所有类别
．缴交製造商证据、选择 GMDN 代码。(如果 GMDN 代码未出现在代码表中，请将详细资讯电子邮件发送至 devices@tga.gov.au)
．缴交製造商的符合性声明。
．缴交产品资料副本：标籤、设备的图片、包装(设备的内包装和外包装) 、使用说明、产品手册、与设备相关的其他手册、医疗器材的广告材料，包括小册子、网页摘录和广告。
．保留作用机制和原理等资料，以证明产品是否符合医疗器材的定义。
．证明遵守基本原则的证据，对于高风险设备须要提供临床证据报告和/或风险管理报告。
．对于III 类医疗器材、AIMD 医疗器材和4 类IVD 医疗器材(属于免疫血液学试剂的4 类IVD 医疗器材除外)，请填写唯一产品标识符(UPI)、功能描述、涵盖的器材总数以及适用的变体类型和变体范围。
．海外监管机构/评估机构的市场授权证据。
．申请人认证、缴交申请费。

标籤
医疗器材的标籤可以用多种语言，但其中一种语言必须是英语，需要标註下列资料：
1.製造商名称或商业名称和地址。
2.设备的预期用途、设备的预期用户以及预期使用该设备的患者类型。
3.提供足够的资讯让用户能够辨识设备或包装内容(如果相关)。
4.适用于设备的任何特定处理方式或储存要求。
5.与设备使用相关的任何警告、限制或预防措施。
6.使用设备的任何特殊操作说明。
4.表明该设备仅供一次性使用(如果适用) 。
8.表明该设备是为特定个人或健康专业人员定制的，并且仅供该个人或健康专业人员使用(如果适用) 。
9.研究用医疗器材，在适用情况下，依分类标示：
．非IVD的医疗器材：该器材用于上市前临床研究。
．IVD的医疗器材：该设备仅用于性能评估。
10.无菌设备须标示STERILE一词以及有关用于对设备进行灭菌的方法的资讯。
11.设备的批次代码、批号或序列号。
12.以清楚的月份、年份方式标示设备可以的安全使用日期 (如果适用)
13.设备製造日期的声明(可能包含在设备的批次代码、批号或序列号中，前提是该日期是清晰可辨的)。
14.出口使用的器材，请註明仅供出口。
15.将医疗器材纳入澳洲治疗产品登记册 (ARTG) 的法律责任人在立法中被称为贊助者，标籤上应标示贊助者的姓名和地址。
16.如果在设备本身或设备使用的包装上无法提供这些详细资讯，则贊助商的名称和地址必须包含在设备随附的单张中。

No, products must be registered on the Australian Register of Therapeutic Goods (ARTG) as an Australian resident or an Australian body corporate.
Process

1. Register TGA business service account (Client ID)
   ．Guarantor: The guarantor must be an Australian resident or an Australian body corporate and have a business in Australia, and the company representative lives in Australia.
   ．Address Details: Street, Suburb/State, Zip Code, Postal Address, Business Contact, Billing Details, Email, Phone, Email.
   ．Organization Manager: Administrator’s full name (responsible for establishing and maintaining connections to the organization), email, phone.
   ．Australian representative: At least one Australian representative must be retained. For overseas agents, please designate the Australian representative of your organization as the authorized contact person. Full name, email, and phone number must be kept.
   ． statement.
   Submit: Email to TGA TBS Help Desk: ebs@health.gov.au
2. Apply for registration in the Australian Register of Therapeutic Goods (ARTG)
   Please submit the materials in English.
   URL: https://reurl.cc/qLxK7R
   Class I Non-Sterile, Non-Measurement, and Class 1 IVD Medical Devices
   ．Submit the manufacturer’s declaration of conformity.
   ．Product information, including: labels, packaging, brochures, catalogs, instructions for use, etc.
   ．Manufacturer and GMDN code (if the GMDN code does not appear in the code table please email details to devices@tga.gov.au)
   ．Applicant certification and payment of application fee.

Class I medical devices (export only) and Class 1 IVD medical devices (export only)
．Submit the manufacturer’s declaration of conformity.
．Select a Manufacturer and provide an export name for the device.
．Applicant certification and payment of application fee.

All categories except Class I non-sterile, non-measuring medical devices, Class 1 IVD medical devices, and Class I medical devices/Export-only Class 1 IVD medical devices
．Submit proof of manufacturer, select GMDN code. (If the GMDN code does not appear in the code table please email details to devices@tga.gov.au)
．Submit the manufacturer’s declaration of conformity.
．Submit copies of product literature: labels, pictures of the device, packaging (inner and outer packaging of the device), instructions for use, product manuals, other manuals related to the device, advertising materials for medical devices, including brochures, web page excerpts and advertisements .
．Information such as the mechanism of action and reasons are retained to prove whether the product meets the definition of a medical device.
．Evidence to demonstrate compliance with basic principles, for high-risk devices, clinical evidence reports and/or risk management reports are required.
．For Class III medical devices, AIMD medical devices, and Class 4 IVD medical devices (except Class 4 IVD medical devices that are immunohematology reagents), please complete the Unique Product Identifier (UPI), Functional Description, Total Devices Covered, and applicable Variant type and variant range.
．Evidence of market authorization from overseas regulators/assessment agencies.
．Applicant certification and payment of application fee.

Label
The labels of medical device can be in multiple languages, but one of the languages must be English, and the following information needs to be marked:

1. Manufacturer’s name or business name and address.
2. The intended use of the device, the intended user of the device, and the type of patients expected to use the device.
3. Provide enough information to allow the user to identify the device or package contents (if relevant).
4. Any specific handling or storage requirements applicable to the device.
5. Any warnings, restrictions, or precautions related to the use of the device.
6. Any special operating instructions for using the device.
7. Indicate that the device is intended for single use only (if applicable).
8. Indicates that the device is custom-made for a specific individual or health professional and is intended for use by that individual or health professional only, if applicable.
9. Medical devices for research, where applicable, marked according to classification:
   ．Non-IVD medical device: The device is used for pre-market clinical research.
   ． Medical Device for IVD: This device is for performance evaluation only.
10. Sterile device must be marked with the word STERILE and information about the method used to sterilize the device.
11. Batch code, lot number or serial number of the device.
12. Mark the safe use date of the device in a clear month and year (if applicable)
13. A statement of the date of manufacture of the device (may be included in the batch code, batch number or serial number of the device, provided the date is clearly identifiable).
14. For the device used for export, please indicate that it is only for export.
15. The person legally responsible for placing a medical device on the Australian Register of Therapeutic Goods (ARTG) is referred to in the legislation as the sponsor and the name and address of the sponsor shall appear on the label.
16. If these details cannot be given on the device itself or on the packaging used with the device, the sponsor’s name and address must be included on the leaflet accompanying the device.

【参考连结】
https://www.legislation.gov.au/Details/F2023C00565
https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/supply-medical-device/medical-device-inclusion-process
https://www.tga.gov.au/resources/resource/guidance/supporting-documentation-inclusion-medical-device

HLF-TW-55

HLF-TW-60
经过核准登记的医疗器材，进口到澳洲要检附什麽文件？经过什麽手续？在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

What documents are required when importing approved medical devices into Australia? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
进口流程

1. 执照和许可证：医疗器材需完成产品註册(ARTG)、商业註册(TGA)。
2. 如为放射性物质需要先行获得澳大利亚辐射防护和核安全局(ARPANSA)的单次/12个月许可证。网页：https://www.arpansa.gov.au/regulation-and-licensing/licensing/import-export-permits/medical-import-permits
3. 估价：所有进入澳洲的进口商品都需要准确估价，以计算相关关税、关税、费用和税费。交易价格以进口货物的实际支付(或应付)价格为基础，并作一定调整。海关在计算交易价值时使用货物出口当天(而不是货物到达澳洲当天)的汇率。
4. 税费、关税和收费
5. 具备澳洲商业号码。
6. 标籤和说明：标籤需要符合规范，以英文标示并且容易阅读。如果商品不符合标籤要求，可能会被扣押。
7. 进口报关(报关单分为三种)：
   ．价值超过1000 澳元的物品的进口报关单。
   ．通过空运或海运到达且价值低于 1000 澳元的物品的自评清关 (SAC) 声明。
   ．价值超过1000 澳元的清关前入库物品的仓库申报单(N20)。
8. 进口需要的资料
   ．贸易合约
   ．装箱单
   ．商业文件(发票)
   ．提单/空运提单
   ．原产地证明文件
   ．许可证。
   ．其他相关文件。

无销售通知。

Import process

1. Licenses and Permits: Medical devices need to complete product registration (ARTG), commercial registration (TGA).
2. If it is radioactive material, it is necessary to obtain a single/12-month license from the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA). Webpage: https://www.arpansa.gov.au/regulation-and-licensing/licensing/import-export-permits/medical-import-permits
3. Valuation: All imported goods into Australia require an accurate valuation in order to calculate relevant duties, duties, fees and taxes. The transaction price is based on the actual payment (or payable) price of the imported goods, with certain adjustments. Customs uses the exchange rate on the day the goods are exported (not the day the goods arrive in Australia) when calculating the transaction value.
4. Taxes, duties and charges
5. Possess an Australian business number.
6. Labeling and Instructions: Labeling needs to be compliant, in English and easy to read. Items may be seized if they do not meet labeling requirements.
7. Import declaration (customs declaration is divided into three types):
   ．Import declarations for items valued at more than A$1000.
   ．Self-Assessed Clearance (SAC) declaration for items arriving by air or sea with a value of less than A$1000.
   ．Warehouse declaration (N20) for goods put into storage prior to customs clearance with a value in excess of AUD 1000.
8. Information required for import
   ．Trade contract
   ．Packing List
   ．Commercial documents (invoices)
   ．Bill of Lading / Air Waybill
   ．Certificate of Origin
   ．License.
   ．Other relevant documents.

No sale notification.

【参考连结】
http://www.customs.gov.au
https://www.abf.gov.au/importing-exporting-and-manufacturing/importing/how-to-import/import-declaration

HLF-TW-70
澳洲医疗器材审核机构，需要附上的实验室检验资料有哪些? 网页？

What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
符合性声明
作为合格评定程序的一部分，医疗器材製造商必须做出合格声明，声明该设备符合：基本原则的适用规定、分类规则、适当的合格评定程序。
．I类(仅限出口)：符合性程序声明。
．I 类(测量)： 完整的品质保证程序/符合性程序声明+验证程序/生产品质保证程序+品质保证程序。
．I 类(无菌)：合格程序声明+生产品质保证程序。
．IIa类：完整的品质保证程序/符合性程序声明+验证程序/生产品质保证程序+产品品质保证程序。
．IIa 类(无菌)：完整的品质保证程序/产品品质保证程序。
．IIb类：完整的品质保证程序/验证程序+型式检验程序/生产品质保证程序+型式检验程序/产品品质保证程序+型式检验程序
．IIb 类(无菌)：完整的品质保证程序/生产品质保证程序+型式检验程序。
．III类：完整的品质保证程序+设计审查/验证程序+型式检验程序/生产品质保证程序+型式检验程序。
．III类(无菌)：完整的品质保证程序+设计审查/生产品质保证程序+型式检验程序。
．AIMD：完整的品质保证程序+设计审查/验证程序+型式检验程序/生产品质保证程序+型式检验程序。

製造商证据
证明製造商已对医疗器材应用适当的合格评定程序的合格评定文件或合格声明。製造商证据用于支持澳洲治疗产品登记册 (ARTG) 中的医疗器材或 IVD 医疗器材。
担保人通过其TBS 系统缴交合格评定文件或合格声明，以获得製造商证据标识。

1. 向 TGA 提供的製造商证据的所有记录(包括信件)必须採用英文或附有经过认证的英文翻译。
2. 可接受的製造商证据：依医疗器材等级规范缴交证明。
   ．TGA 合格评定证书。
   ．海外国家监管机构的与製造商品质管理体系相关的海外市场授权证据或合格评定文件
   ．符合性声明。

QMS认证
医疗器材合格评定程序的两个种点要求是製造商必须实施：
1.用于设备设计、生产、包装、标籤和最终检验的品质管理体系(QMS)。
2.在设备生产过程中应用的检查和品质保证技术。
3.ISO 13485 的结构由八部分组成，前三部分主要是介绍性，后五部分包含医疗器材品质管理体系的要求，包含以下：
．品质管理体系：记录控制、品质手册和文件控制，满足医疗器材品质管理体系的文件要求。
．管理层责任：最高管理层有效实施医疗器材品质管理体系的责任。必须定期审查正在进行的流程，以确保管理体系的效率。
．资源管理：规定调动资源实施医疗器材品质管理体系的方法。包括人力资源、基础设施资源等。
．产品实现：导致产品开发的所有流程，包括用于监控和测量产品和过程的设备设计、购买和控制。
．测量、分析和改进：包括监控和测量品质管理体系的效率和有效性的要求。透过客户满意度评估、内部审核、定期监控产品和流程、分析不合格者以及採取纠正和预防措施完成。

Declaration of Conformity
As part of the conformity assessment procedure, medical device manufacturers must make a declaration of conformity stating that the device complies with: the applicable provisions of the fundamental principles, the classification rules, the appropriate conformity assessment procedure.
．Class I (export only): Declaration of Conformity Procedures.
．Class I (Measurement): Complete quality assurance program/declaration of conformity program + verification program/production quality assurance program + quality assurance program.
．Class I (sterility): Declaration of Conformity Procedures + Manufacturing Quality Assurance Procedures.
．Class IIa: complete quality assurance program/conformity program statement + verification program/production quality assurance program + product quality assurance program.
．Class IIa (sterile): Complete QA program/Product QA program.
．Class IIb: complete quality assurance program/verification program + type inspection program/production quality assurance program + type inspection program/product quality assurance program + type inspection program
．Class IIb (sterile): Complete quality assurance procedures/production quality assurance procedures + type inspection procedures.
．Class III: Complete quality assurance procedures + design review/verification procedures + type inspection procedures/production quality assurance procedures + type inspection procedures.
．Class III (sterility): complete quality assurance program + design review/production quality assurance program + type inspection program.
．AIMD: Complete quality assurance program + design review/verification program + type inspection program/production quality assurance program + type inspection program.

Manufacturer evidence
A conformity assessment document or declaration of conformity that demonstrates that the manufacturer has applied the appropriate conformity assessment procedures to the medical device. Manufacturer evidence is used to support medical devices or IVD medical devices on the Australian Register of Therapeutic Goods (ARTG).
The guarantor submits the conformity assessment document or declaration of conformity through its TBS system to obtain the manufacturer’s evidence mark.

1. All records (including letters) of manufacturer evidence provided to the TGA must be in English or accompanied by a certified English translation.
2. Acceptable manufacturer’s evidence: Submit the certificate in accordance with the medical device grade specification.
   ．GA Conformity Assessment Certificate.
   ．Overseas market authorization evidence or conformity assessment documents related to the manufacturer’s quality management system from overseas national regulatory agencies
   ．Declaration of Conformity.

QMS certification
There are two key requirements of the medical device conformity assessment procedure that manufacturers must implement:

1. Quality Management System (QMS) for device design, production, packaging, labeling and final inspection.
2. Inspection and quality assurance techniques applied during device production.
3. The structure of ISO 13485 consists of eight parts. The first three parts are mainly introductory, and the last five parts contain the requirements for the quality management system of medical devices, including the following:
   ． Quality management system: record control, quality manual and document control, meeting the document requirements of the medical device quality management system.
   ．Management Responsibility: The responsibility of the top management to effectively implement the medical device quality management system. Ongoing processes must be reviewed regularly to ensure the effectiveness of the management system.
   ．Resource management: specifies the method for mobilizing resources to implement the medical device quality management system. Including human resources, infrastructure resources, etc.
   ．Product Realization: All processes leading to product development, including design, purchase, and control of device used to monitor and measure products and processes.
   ．Measurement, Analysis and Improvement: Includes requirements for monitoring and measuring the efficiency and effectiveness of the quality management system. This is accomplished through customer satisfaction assessments, internal audits, regular monitoring of products and processes, analysis of nonconformities, and adoption of corrective and preventive actions.

【参考连结】
https://www.tga.gov.au/manufacturer-evidence-medical-devices-including-ivd-medical-devices
https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/obtain-and-maintain-regulatory-evidence/tga-conformity-assessment/australian-declaration-conformity-templates-medical-devices
https://www.tga.gov.au/guidance-therapeutic-goods-conformity-assessment-standard-quality-management-systems-order-2019

HLF-TW-75

HLF-TW-77

HLF-TW-80
外国子公司进口医疗器材后，如果委託澳洲的经销商销售，经销商需要医疗器材营业许可证吗？假如医疗器材有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？

After a foreign subsidiary imports medical devices and entrusts a distributor in Australia to sell it, does the distributor need a medical devices business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
经销商无须营业许可证。

产品责任
1.当发生医疗器材不良事件，医疗器材的产品註册者(担保人)必须报告TGA(强制)，包含：初步报告、后续报告和最终报告。
2.供应商、批发商、分销商、进口商和製造商有责任监督医疗器材产品安全，当有发现产品安全问题时，必须向ACCC提出报告(强制)。

Distributors do not require a business license.

Product liability

1. When a medical device adverse event occurs, the product registrant (guarantor) of the medical device must report TGA (mandatory), including: initial report, follow-up report and final report.
2. Suppliers, wholesalers, distributors, importers and manufacturers are responsible for supervising the safety of medical device products. When product safety problems are found, they must report to ACCC (mandatory).

【参考连结】
https://www.tga.gov.au/resources/resource/forms/report-medical-device-adverse-event-sponsormanufacturer
https://www.accc.gov.au/business/selling-products-and-services/product-safety-responsibilities#toc-ensure-products-you-sell-are-safe
https://www.tga.gov.au/products/medical-devices
https://apps.tga.gov.au/prod/mdir/mdirsummary.aspx?sid=1427158301

HLF-TW-85

各国医疗器材登记法规问答集

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