Medical Device Regulations and Registration Process in TGA Australia
Medical Devices market in Australia is estimated to reach USD 6.34bn in 2023 with the market's largest contributor being Cardiology Devices with a projected market volume of USD 0.92bn in 2023.
Revenue is expected to show an annual growth rate (CAGR) of 6.08% between 2023-2028, resulting in a market volume of USD 8.52 billion by 2028.
Regulatory Authority in Australia
Medical devices in Australia shall be approved by the Australian regulatory authority, Therapeutic Goods Administration (TGA). The TGA is part of the Australian Government Department of Health and is responsible for ensuring the safety, quality, and effectiveness of therapeutic goods, including medical devices, in the Australian market. TGA regulations for medical devices are provided under Therapeutic Goods (Medical Device) Regulation 2002 and the Australian regulatory guidelines for medical devices (ARGMD)
Medical Device Classification and Labeling Requirements
The Australian medical device classification system consists of four main classes based on the risk associated:
Class I: Low Risk
Low-risk devices are the ones with a well-established safety profile. Examples include non-invasive instruments, bandages, and dental instruments.
Devices are required to be labeled with the name and address of the Australian sponsor or manufacturer, device description, instructions for use (if necessary), and any warnings or precautions relevant to the device.
Class IIa: Low to Medium Risk
Medium-risk devices are of a higher risk than Class I devices with a moderate risk profile. Examples include contact lenses, surgical instruments, and certain diagnostic devices.
Class IIb: Medium to High Risk
Devices that are of higher risk than Class IIa devices that may be used in critical body areas or have a prolonged duration of use. Examples include implantable devices, some active therapeutic devices, and certain in-vitro diagnostic devices.
Class III: High Risk
Class III devices are the ones with the highest risk to patients and often require special controls or oversight. Examples include life-supporting and life-sustaining devices, heart valves, and some implantable devices.
Labeling Requirements for Higher class devices:
Comprehensive labeling is required for higher-class devices to ensure safety and appropriate use.
In addition to the requirements for Class I devices, Class IIa, IIb, and III devices should include information such as intended purpose, indications for use, contraindications, precautions, side effects, storage conditions, batch/lot numbers, and expiry dates.
Instructions for use, including device preparation, handling, and any specific technique requirements, should be provided.
For implantable devices or devices used in critical body areas, additional information on the materials used, sterilization instructions, and any necessary warnings or precautions should be included.
As per Australian regulations, all medical devices must follow Global Medical Device Nomenclature (GMDN) guidelines.
Clinical Trial Requirements for Medical Device Registration in TGA Australia:
Before initiating a clinical trial, researchers must obtain an Investigational Device Exemption (IDE) from the TGA. The IDE application includes information about the device, its intended use, its investigational plan, and evidence supporting its safety and performance. The IDE application is reviewed by the TGA, which assesses the scientific validity of the clinical trial.
Ethical Committee Approval: All clinical trials involving medical devices in Australia must receive approval from a Human Research Ethics Committee (HREC). The HREC evaluates the ethical aspects of the trial, including participant safety, informed consent procedures, privacy and data protection, and the scientific merit of the study.
Informed Consent: Informed consent is a critical requirement for clinical trials. Participants must be provided with clear and understandable information about the trial, its objectives, potential risks, and benefits. The participant's voluntary consent to participate in the trial is essential before initiating the study, and they should have the opportunity to raise queries and/or withdraw from the study at any time.
Good Clinical Practice (GCP): Clinical trials must adhere to Good Clinical Practice guidelines, which provide standards for the design, conduct, monitoring, and reporting of clinical trials. GCP ensures that trials are conducted with integrity, participant safety is prioritized, and the data generated is reliable and accurate.
Reporting Requirements: Researchers are required to report adverse events, unexpected or serious device-related incidents, and any changes to the investigational plan to the TGA and ethics committee. The TGA also requires regular updates on the progress of the trial, including interim reports, final reports, and study outcomes.
Product Testing Requirements
Medical devices in Australia may need to comply with the regulatory requirements set by the TGA which specify certain testing standards and procedures for medical devices based on their risk classification and intended use. This may include testing for biological safety, electromagnetic compatibility, performance evaluation, and sterilization validation depending on the device type.
Product testing is typically performed by accredited testing laboratories that have the necessary expertise, equipment, and facilities to conduct the required tests. These laboratories should meet specific accreditation criteria to ensure the reliability and accuracy of their testing results.
Conformity Assessment:
Higher-class medical devices require a formal conformity assessment process conducted by a Conformity Assessment Body (CAB) recognized by the TGA.
The CAB assesses the manufacturer's quality management system and reviews technical documentation, including design, manufacturing processes, and clinical evidence. Manufacturers need to have a certified Quality Management System (QMS) which is compliant with the relevant standard, such as ISO 13485, and be audited by the CAB or CB during the conformity assessment process.
The assessment may also involve testing and inspection of the device to verify compliance with relevant standards and requirements.
The CAB issues a Conformity Assessment Certificate to the manufacturer upon successful completion of the assessment.
Certification Bodies: For higher-risk devices, the TGA may require the involvement of a third-party Certification Body (CB) in the conformity assessment process.
Class I devices are exempted from the TGA assessment and do not require conformity assessment.
Registration Process
Local Representative: The local representative can be an individual or an organization, such as a sponsor, distributor, or regulatory consultant, who has a physical presence in Australia. The Local representative serves as the primary point of contact between the manufacturer and the TGA.
Technical Documentation: Technical documentation that demonstrates the safety, quality, and performance of the medical device. The documentation includes.
Medical Device Application
Technical Files such as device description, intended purpose, design and manufacturing details, labeling, risk assessment, and clinical evidence (if required)
Australian Declaration of Conformity
Manufacturer’s Evidence (CE Certificate)
Appointment of Australian Sponsor
Pre-Market Evaluation
For higher-risk device classes such as Class IIb and III, a pre-market evaluation may be required. This evaluation involves the TGA reviewing the technical documentation to assess the device's conformity with regulatory requirements. These classes of devices undergo a comprehensive assessment, including a review of clinical data and performance evaluation.
Application Submission:
An application for market authorization is submitted to the TGA, which includes the completed application form, technical documentation, and applicable fees. The TGA provides an online portal called the Australian Register of Therapeutic Goods (ARTG) where applications can be submitted.
Australia TGA Medical Devices Registration Review process and Approval:
The TGA reviews the application and technical documentation for Australia Medical Devices to assess the device's safety, quality, and performance. If the TGA determines that the device meets the necessary requirements, it will be granted inclusion on the ARTG, which allows the device to be legally supplied and marketed in Australia.
Australia TGA Medical Devices Regulations Registration Timelines: For Class I & II a, typically about 4 weeks, and for Class IIb 6 weeks is required. Class III & Active Implantable Medical Device needs about 6 months.
Annual charges:
An annual fee is applicable for the inclusion of Australia TGA medical devices registration in the Australian Register of Therapeutic Goods (ARTG).
As per the update on the fee summary released in July 2023 by TGA, the following charges are applicable based on the device class:
Device class with Annual applicable charges
Class III & Active Implantable Medical Device (AIMD)$1,394
Class III $1,394
Class IIa & b $1,095
Class I – sterile and measuring devices $749
Other Class I devices$103
The US/EU approval is beneficial for gaining Market authorization in Australia, the TGA recognizes the international regulations from the established authorities such as FDA and EMA. TGA accepts conformity assessment reports, clinical data, and risk assessment documents generated during the EU/US approval. Thereby, the US/EU approval can provide valuable supporting evidence and streamline the registration process in Australia.
Import and Distribution Requirements:
Importers and distributors of medical devices in Australia are generally required to have a valid Medical Device Establishment License (MDEL) issued by the TGA. The MDEL demonstrates that the establishment has the necessary systems and processes in place to handle and distribute medical devices in accordance with regulatory requirements.
Before importing or distributing a medical device, it must be included on the ARTG, which is a database of all therapeutic goods authorized for supply in Australia.
Import medical devices must comply with applicable importation and distribution regulations including compliance with relevant Australian Standards, conformity assessment requirements, labeling and advertising regulations, and post-market obligations.
Good Distribution Practices: Importers and distributors should adhere to appropriate storage, handling, and distribution practices to ensure the integrity and quality of the medical devices during transportation, storage, and throughout the supply chain.
Post-Marketing Surveillance
After a medical device has been included in the ARTG, the device is expected to continue to meet all the regulatory, safety, and performance requirements and standards. The Therapeutic Goods Administration (TGA) has well-defined requirements and processes for post-market surveillance to monitor the safety and effectiveness of medical devices. Continuous monitoring of device performance and systematic investigation of failures and/or deviations in the way a device performs is warranted to ensure safety.
Adverse Event Reporting: Manufacturers and sponsors are required to report adverse events associated with medical devices to the TGA.
Mandatory Problem Reporting: Manufacturers are required to report certain types of problems such as device malfunctions, defects, or any other issues that could affect the device's safety or performance to the TGA.
Field Safety Corrective Actions: TGA may require manufacturers to take actions to address any concerns that may arise post-marketing of the device. These actions may include issuing field safety notices, conducting device recalls or corrections, or implementing other appropriate measures such as Corrective Action and Preventive Action (CAPA) to mitigate risks associated with the device.
For more details on the regulatory process, get in touch with Artixio, a globally trusted consultant for regulatory assistance.
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