Australia medical device regulations QA

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Email: syd4ww@evershinecpa.com
Australia CA Lily Yan, speak both English and Chinese
2/172-176 Rowe St Eastwood, NSW 2122, Australia

時間：2023/08/24 drafted by Yvonne Chen

HLF-TW-10
]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：

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.

【reference link】
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
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：
No business license.

【reference link】
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
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：

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).

【reference link】
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
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：

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.

【reference link】
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
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：

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.

【reference link】
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
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：

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.

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

HLF-TW-70
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：

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.

【reference link】
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
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：

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).

【reference link】
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

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2/172-176 Rowe St Eastwood, NSW 2122, Australia
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