澳洲醫療器材登記法規問題集

Email：mel4ww@evershinecpa.com
或
澳洲永輝BPO有限公司
Melbourne time zone:
The Engaging Manager CA Lily Yan, 澳大利亞籍說中英文
或
China Time Zone:
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199 in Taiwan; Mobile: +86-139-1048-6278 in China
TEL: +886-2-27170515 E100 ;
Wechat id:evershiinecpa;
Line Id: evershinecpa
Skype: daleccchen ;
linkedin address:Dale Chen Linkedin

各國醫療器材登記法規問答集

時間：2023/08/24 drafted by Yvonne Chen

HLF-TW-10
請問澳洲對於醫療器材的歸類方式為何？它的正式名稱為何？不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？

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：
澳洲的醫療器材由治療用品管理局 (TGA) 監管，負責評估和監控醫療器材。
醫療器材是指製造為單獨或組合用於人類的任何儀器、裝置、器具、機器、器具、植入物、體外試劑或校準器、軟件、材料或其他類似或相關物品，用於以下一個或多個特定目的：
1.診斷、預防、監測、預測、預後、治療或緩解疾病。
2.損傷的診斷、監測、治療、減輕或補償。
3.解剖結構或生理過程的調查、替換、修改或支持。
4.支持或維持生命。
5.通過對人體標本進行體外檢查，為醫療或診斷目的提供資訊。該裝置不能通過藥理學、免疫學或代謝手段在人體內或人體上實現其主要預期作用，但可以通過這些手段輔助其達到預期功能。

醫療器材根據對人體的風險程度有不同的分類：
一、IVD 分類
1.第1級：無公共衛生風險或個人風險低。
2.第2級：低公共衛生風險或中等個人風險。
3.第3級：中等公共衛生風險或高個人風險。
4.第4級：高公共衛生風險。

二、醫療器材分類(非 IVD)

1. I類：風險等級低。
2. Is類(無菌)、Im類(具有測量功能)、IIa類 ：風險等級低到中。
3. IIb類：風險等級中到高。
4. III類：風險等級高。

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.

【參考連結】
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
外國公司要到澳洲銷售醫療器材，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？

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：
無營業特許證。
No business license.

【參考連結】
https://www.tga.gov.au/products/medical-devices

HLF-TW-25
假如需要辦理，請問澳洲有專業服務公司可以協助辦理醫療器材公司營業許可證？
Evershine RD：
無營業特許證。
No business license.

HLF-TW-30
外國公司要到澳洲銷售醫療器材，可以指派澳洲公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？

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。營業代理人無特殊條件要求。

產品責任
1.當發生醫療器材不良事件，醫療器材的產品註冊者(擔保人)必須報告TGA(強制)，包含：初步報告、後續報告和最終報告。

2.供應商、批發商、分銷商、進口商和製造商有責任監督醫療器材產品安全，當有發現產品安全問題時，必須向ACCC提出報告(強制)。

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).

【參考連結】
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
外國公司銷售到澳洲醫療器材本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？

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，須以澳洲居民或澳洲的法人團體身分將產品註冊在澳洲治療產品登記冊(ARTG) 中。

流程
1.註冊TGA 商業服務帳號 (Client ID)
．擔保人：擔保人必須是澳洲居民或澳洲的法人團體並有在澳洲開展業務，且公司代表居住在澳洲。
．詳細地址：街道、郊區/州、郵政編碼、郵寄地址、公司聯繫方式、賬單詳細訊息、電子郵件、電話、電子郵件。
．組織管理者：管理員全名(負責建立和維護組織的聯繫)、電子郵件、電話。
．澳洲代表：必須保留至少一名澳洲代表，境外代理商請指定您所在組織的澳洲代表作為授權聯繫人，需留存全名、電子郵件、電話。
．聲明。
繳交：電子郵件交至 TGA TBS 服務台：ebs@health.gov.au

2.申請註冊澳洲治療產品登記冊(ARTG)
繳交資料請以英語方式呈現。
網頁：https://reurl.cc/qLxK7R
I 類非無菌、非測量和 1 類 IVD 醫療器材
．繳交製造商的符合性聲明。
．產品資訊，包括：標籤、包裝、宣傳冊、目錄、使用說明等。
．製造商和 GMDN 代碼(如果 GMDN 代碼未出現在代碼表中，請將詳細資訊電子郵件發送至 devices@tga.gov.au)
．申請人認證、繳交申請費。

I 類醫療器材(僅出口)和 1 類 IVD 醫療器材(僅出口)
．繳交製造商的符合性聲明。
．選擇製造商並提供設備的出口名稱。
．申請人認證、繳交申請費。

I 類非無菌、非測量醫療器材、1 類 IVD 醫療器材和 I 類醫療器材/僅限出口的 1 類 IVD 醫療器材之外的所有類別
．繳交製造商證據、選擇 GMDN 代碼。(如果 GMDN 代碼未出現在代碼表中，請將詳細資訊電子郵件發送至 devices@tga.gov.au)
．繳交製造商的符合性聲明。
．繳交產品資料副本：標籤、設備的圖片、包裝(設備的內包裝和外包裝) 、使用說明、產品手冊、與設備相關的其他手冊、醫療器材的廣告材料，包括小冊子、網頁摘錄和廣告。
．保留作用機制和原理等資料，以證明產品是否符合醫療器材的定義。
．證明遵守基本原則的證據，對於高風險設備須要提供臨床證據報告和/或風險管理報告。
．對於III 類醫療器材、AIMD 醫療器材和4 類IVD 醫療器材(屬於免疫血液學試劑的4 類IVD 醫療器材除外)，請填寫唯一產品標識符(UPI)、功能描述、涵蓋的器材總數以及適用的變體類型和變體範圍。
．海外監管機構/評估機構的市場授權證據。
．申請人認證、繳交申請費。

標籤
醫療器材的標籤可以用多種語言，但其中一種語言必須是英語，需要標註下列資料：
1.製造商名稱或商業名稱和地址。
2.設備的預期用途、設備的預期用戶以及預期使用該設備的患者類型。
3.提供足夠的資訊讓用戶能夠辨識設備或包裝內容(如果相關)。
4.適用於設備的任何特定處理方式或儲存要求。
5.與設備使用相關的任何警告、限制或預防措施。
6.使用設備的任何特殊操作說明。
4.表明該設備僅供一次性使用(如果適用) 。
8.表明該設備是為特定個人或健康專業人員定制的，並且僅供該個人或健康專業人員使用(如果適用) 。
9.研究用醫療器材，在適用情況下，依分類標示：
．非IVD的醫療器材：該器材用於上市前臨床研究。
．IVD的醫療器材：該設備僅用於性能評估。
10.無菌設備須標示STERILE一詞以及有關用於對設備進行滅菌的方法的資訊。
11.設備的批次代碼、批號或序列號。
12.以清楚的月份、年份方式標示設備可以的安全使用日期 (如果適用)
13.設備製造日期的聲明(可能包含在設備的批次代碼、批號或序列號中，前提是該日期是清晰可辨的)。
14.出口使用的器材，請註明僅供出口。
15.將醫療器材納入澳洲治療產品登記冊 (ARTG) 的法律責任人在立法中被稱為贊助者，標籤上應標示贊助者的姓名和地址。
16.如果在設備本身或設備使用的包裝上無法提供這些詳細資訊，則贊助商的名稱和地址必須包含在設備隨附的單張中。

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.

【參考連結】
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
外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？？網頁？

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，須以澳洲居民或澳洲的法人團體身分將產品註冊在澳洲治療產品登記冊(ARTG) 中。

流程
1.註冊TGA 商業服務帳號 (Client ID)
．擔保人：擔保人必須是澳洲居民或澳洲的法人團體並有在澳洲開展業務，且公司代表居住在澳洲。
．詳細地址：街道、郊區/州、郵政編碼、郵寄地址、公司聯繫方式、賬單詳細訊息、電子郵件、電話、電子郵件。
．組織管理者：管理員全名(負責建立和維護組織的聯繫)、電子郵件、電話。
．澳洲代表：必須保留至少一名澳洲代表，境外代理商請指定您所在組織的澳洲代表作為授權聯繫人，需留存全名、電子郵件、電話。
．聲明。
繳交：電子郵件交至 TGA TBS 服務台：ebs@health.gov.au

2.申請註冊澳洲治療產品登記冊(ARTG)
繳交資料請以英語方式呈現。
網頁：https://reurl.cc/qLxK7R
I 類非無菌、非測量和 1 類 IVD 醫療器材
．繳交製造商的符合性聲明。
．產品資訊，包括：標籤、包裝、宣傳冊、目錄、使用說明等。
．製造商和 GMDN 代碼(如果 GMDN 代碼未出現在代碼表中，請將詳細資訊電子郵件發送至 devices@tga.gov.au)
．申請人認證、繳交申請費。

I 類醫療器材(僅出口)和 1 類 IVD 醫療器材(僅出口)
．繳交製造商的符合性聲明。
．選擇製造商並提供設備的出口名稱。
．申請人認證、繳交申請費。

I 類非無菌、非測量醫療器材、1 類 IVD 醫療器材和 I 類醫療器材/僅限出口的 1 類 IVD 醫療器材之外的所有類別
．繳交製造商證據、選擇 GMDN 代碼。(如果 GMDN 代碼未出現在代碼表中，請將詳細資訊電子郵件發送至 devices@tga.gov.au)
．繳交製造商的符合性聲明。
．繳交產品資料副本：標籤、設備的圖片、包裝(設備的內包裝和外包裝) 、使用說明、產品手冊、與設備相關的其他手冊、醫療器材的廣告材料，包括小冊子、網頁摘錄和廣告。
．保留作用機制和原理等資料，以證明產品是否符合醫療器材的定義。
．證明遵守基本原則的證據，對於高風險設備須要提供臨床證據報告和/或風險管理報告。
．對於III 類醫療器材、AIMD 醫療器材和4 類IVD 醫療器材(屬於免疫血液學試劑的4 類IVD 醫療器材除外)，請填寫唯一產品標識符(UPI)、功能描述、涵蓋的器材總數以及適用的變體類型和變體範圍。
．海外監管機構/評估機構的市場授權證據。
．申請人認證、繳交申請費。

標籤
醫療器材的標籤可以用多種語言，但其中一種語言必須是英語，需要標註下列資料：
1.製造商名稱或商業名稱和地址。
2.設備的預期用途、設備的預期用戶以及預期使用該設備的患者類型。
3.提供足夠的資訊讓用戶能夠辨識設備或包裝內容(如果相關)。
4.適用於設備的任何特定處理方式或儲存要求。
5.與設備使用相關的任何警告、限制或預防措施。
6.使用設備的任何特殊操作說明。
4.表明該設備僅供一次性使用(如果適用) 。
8.表明該設備是為特定個人或健康專業人員定制的，並且僅供該個人或健康專業人員使用(如果適用) 。
9.研究用醫療器材，在適用情況下，依分類標示：
．非IVD的醫療器材：該器材用於上市前臨床研究。
．IVD的醫療器材：該設備僅用於性能評估。
10.無菌設備須標示STERILE一詞以及有關用於對設備進行滅菌的方法的資訊。
11.設備的批次代碼、批號或序列號。
12.以清楚的月份、年份方式標示設備可以的安全使用日期 (如果適用)
13.設備製造日期的聲明(可能包含在設備的批次代碼、批號或序列號中，前提是該日期是清晰可辨的)。
14.出口使用的器材，請註明僅供出口。
15.將醫療器材納入澳洲治療產品登記冊 (ARTG) 的法律責任人在立法中被稱為贊助者，標籤上應標示贊助者的姓名和地址。
16.如果在設備本身或設備使用的包裝上無法提供這些詳細資訊，則贊助商的名稱和地址必須包含在設備隨附的單張中。

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.

【參考連結】
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
經過核准登記的醫療器材，進口到澳洲要檢附什麼文件？經過什麼手續？在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？

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：
進口流程

1. 執照和許可證：醫療器材需完成產品註冊(ARTG)、商業註冊(TGA)。
2. 如為放射性物質需要先行獲得澳大利亞輻射防護和核安全局(ARPANSA)的單次/12個月許可證。網頁：https://www.arpansa.gov.au/regulation-and-licensing/licensing/import-export-permits/medical-import-permits
3. 估價：所有進入澳洲的進口商品都需要準確估價，以計算相關關稅、關稅、費用和稅費。交易價格以進口貨物的實際支付(或應付)價格為基礎，並作一定調整。海關在計算交易價值時使用貨物出口當天(而不是貨物到達澳洲當天)的匯率。
4. 稅費、關稅和收費
5. 具備澳洲商業號碼。
6. 標籤和說明：標籤需要符合規範，以英文標示並且容易閱讀。如果商品不符合標籤要求，可能會被扣押。
7. 進口報關(報關單分為三種)：
   ．價值超過1000 澳元的物品的進口報關單。
   ．通過空運或海運到達且價值低於 1000 澳元的物品的自評清關 (SAC) 聲明。
   ．價值超過1000 澳元的清關前入庫物品的倉庫申報單(N20)。
8. 進口需要的資料
   ．貿易合約
   ．裝箱單
   ．商業文件(發票)
   ．提單/空運提單
   ．原產地證明文件
   ．許可證。
   ．其他相關文件。

無銷售通知。

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.

【參考連結】
http://www.customs.gov.au
https://www.abf.gov.au/importing-exporting-and-manufacturing/importing/how-to-import/import-declaration

HLF-TW-70
澳洲醫療器材審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
符合性聲明
作為合格評定程序的一部分，醫療器材製造商必須做出合格聲明，聲明該設備符合：基本原則的適用規定、分類規則、適當的合格評定程序。
．I類(僅限出口)：符合性程序聲明。
．I 類(測量)： 完整的品質保證程序/符合性程序聲明+驗證程序/生產品質保證程序+品質保證程序。
．I 類(無菌)：合格程序聲明+生產品質保證程序。
．IIa類：完整的品質保證程序/符合性程序聲明+驗證程序/生產品質保證程序+產品品質保證程序。
．IIa 類(無菌)：完整的品質保證程序/產品品質保證程序。
．IIb類：完整的品質保證程序/驗證程序+型式檢驗程序/生產品質保證程序+型式檢驗程序/產品品質保證程序+型式檢驗程序
．IIb 類(無菌)：完整的品質保證程序/生產品質保證程序+型式檢驗程序。
．III類：完整的品質保證程序+設計審查/驗證程序+型式檢驗程序/生產品質保證程序+型式檢驗程序。
．III類(無菌)：完整的品質保證程序+設計審查/生產品質保證程序+型式檢驗程序。
．AIMD：完整的品質保證程序+設計審查/驗證程序+型式檢驗程序/生產品質保證程序+型式檢驗程序。

製造商證據
證明製造商已對醫療器材應用適當的合格評定程序的合格評定文件或合格聲明。製造商證據用於支持澳洲治療產品登記冊 (ARTG) 中的醫療器材或 IVD 醫療器材。
擔保人通過其TBS 系統繳交合格評定文件或合格聲明，以獲得製造商證據標識。

1. 向 TGA 提供的製造商證據的所有記錄(包括信件)必須採用英文或附有經過認證的英文翻譯。
2. 可接受的製造商證據：依醫療器材等級規範繳交證明。
   ．TGA 合格評定證書。
   ．海外國家監管機構的與製造商品質管理體系相關的海外市場授權證據或合格評定文件
   ．符合性聲明。

QMS認證
醫療器材合格評定程序的兩個種點要求是製造商必須實施：
1.用於設備設計、生產、包裝、標籤和最終檢驗的品質管理體系(QMS)。
2.在設備生產過程中應用的檢查和品質保證技術。
3.ISO 13485 的結構由八部分組成，前三部分主要是介紹性，後五部分包含醫療器材品質管理體系的要求，包含以下：
．品質管理體系：記錄控制、品質手冊和文件控制，滿足醫療器材品質管理體系的文件要求。
．管理層責任：最高管理層有效實施醫療器材品質管理體系的責任。必須定期審查正在進行的流程，以確保管理體系的效率。
．資源管理：規定調動資源實施醫療器材品質管理體系的方法。包括人力資源、基礎設施資源等。
．產品實現：導致產品開發的所有流程，包括用於監控和測量產品和過程的設備設計、購買和控制。
．測量、分析和改進：包括監控和測量品質管理體系的效率和有效性的要求。透過客戶滿意度評估、內部審核、定期監控產品和流程、分析不合格者以及採取糾正和預防措施完成。

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.

【參考連結】
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
外國子公司進口醫療器材後，如果委託澳洲的經銷商銷售，經銷商需要醫療器材營業許可證嗎？假如醫療器材有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？

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：
經銷商無須營業許可證。

產品責任
1.當發生醫療器材不良事件，醫療器材的產品註冊者(擔保人)必須報告TGA(強制)，包含：初步報告、後續報告和最終報告。
2.供應商、批發商、分銷商、進口商和製造商有責任監督醫療器材產品安全，當有發現產品安全問題時，必須向ACCC提出報告(強制)。

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).

【參考連結】
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

各國醫療器材登記法規問答集

聯繫人：
Email：mel4ww@evershinecpa.com
或
澳洲永輝BPO有限公司
Melbourne time zone:
The Engaging Manager CA Lily Yan, 澳大利亞籍說中英文
或
China Time Zone:
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199 in Taiwan; Mobile: +86-139-1048-6278 in China
TEL: +886-2-27170515 E100 ;
Wechat id:evershiinecpa;
Line Id: evershinecpa
Skype: daleccchen ;
linkedin address:Dale Chen Linkedin
全球永輝服務據點參考資料:
永輝100%關係企業
永輝總部、臺北永輝、廈門永輝、北京永輝、上海那靈、深圳常新、紐約永輝、加州永輝、德州永輝、鳳凰城永輝、東京永輝、首爾永輝、河內永輝、越南胡志明、曼谷永輝、新加坡永輝、吉隆玻永輝、雅加達永輝、馬尼拉永輝、墨爾本永輝、澳洲雪梨、孟加拉永輝、新德里永輝、印度孟買、杜拜永輝、法蘭克福永輝、巴黎永輝、倫敦永輝、荷蘭永輝、西班牙永輝、義大利永輝、羅馬尼亞永輝、多倫多永輝、墨西哥永輝。
其他已提供中文化服務城市：
邁阿密、亞特蘭大、俄克拉荷馬、密歇根、西雅圖、特拉華；
柏林; 斯圖加特;布拉格；布加勒斯特；班加羅爾；泗水；
高雄、香港、深圳、東關、廣州、清遠、永康、杭州、蘇州、崑山、南京、重慶、許昌、青島、天津。
永輝潛在可服務城市 (2個月籌備期)：
我們為IAPA會員所,總部在倫敦，全球300個會員所，員工約1萬人。
我們為LEA會員所,總部在美國芝加哥，全球600個會員所，員工約2萬8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)
更多城市更多服務  請點擊 網站導覽