Before applying for Class I medical device registration with the Australian Therapeutic Goods Administration (TGA), it’s crucial to conduct thorough preparation to ensure compliance with all regulatory requirements. Here’s a guide to the key preparatory steps and considerations:

1. Understand the Device Classification

• Verify the Device’s Classification: Ensure that your medical device falls under Class I according to the TGA’s classification rules. Class I is the lowest risk category and includes non-invasive devices.

  • Class I (Non-sterile, Non-measuring): The simplest form of Class I device.
  • Class Is (Sterile): Class I devices supplied in a sterile condition.
  • Class Im (Measuring): Class I devices with a measuring function.

• Consult TGA Guidance: Use TGA’s classification flowcharts and guidance documents to confirm that your device is appropriately classified. Misclassification can lead to application delays or rejections.

2. Regulatory Framework Familiarization

• Familiarize Yourself with the Therapeutic Goods Act and Regulations: Gain a working knowledge of the Therapeutic Goods Act 1989, Therapeutic Goods Regulations 2002, and TGA’s regulatory framework for medical devices.

• Essential Principles: Understand the Essential Principles of safety and performance that your device must meet. These principles cover aspects such as device design, safety, labeling, and instructions for use.

3. Quality Management System (QMS) Compliance

• Implement a QMS (ISO 13485): While Class I devices are low-risk, the manufacturer is expected to follow good manufacturing practices. Having a Quality Management System (QMS) in place that complies with ISO 13485 demonstrates that you meet international standards for the design, production, and control of medical devices.

• Prepare Manufacturer’s Evidence: Ensure that your quality management system can generate necessary documentation, such as the Declaration of Conformity and other technical files required by the TGA.

4. Risk Management Process

• ISO 14971 Compliance: Implement a risk management system according to ISO 14971. Even for low-risk Class I devices, manufacturers must perform risk assessments to identify, evaluate, and mitigate potential risks associated with the use of the device.

• Prepare a Risk Management File: Include your risk analysis and the steps taken to ensure device safety. This will form part of your technical documentation.

5. Device Technical Documentation

• Compile Comprehensive Technical Documentation: Your documentation must demonstrate compliance with the Essential Principles and should include:
  • Device Description: Detailed description of the device’s function, purpose, and key specifications.
  • Design and Manufacturing Process: Information on how the device is designed and manufactured, including materials used.
  • Risk Management File: Evidence of risk assessments and mitigation measures.
  • Instructions for Use (IFU): Clear and precise instructions for the use of the device, along with any relevant warnings or precautions.
  • Labeling: Ensure that the device’s labeling complies with TGA requirements, including product identification, manufacturer information, and any safety warnings.
  • Clinical Evidence (if applicable): While Class I devices generally do not require extensive clinical data, if your device has a clinical component, relevant evidence of its safety and performance must be included.

6. Appoint an Australian Sponsor

• Find an Australian Sponsor: If the manufacturer is located outside of Australia, you are required to appoint an Australian Sponsor. The sponsor is responsible for submitting the application, acting as the main contact with the TGA, and ensuring regulatory compliance.

  • The sponsor must:
    • Be an Australian resident or entity.
    • Have access to the technical documentation and regulatory information about the device.
    • Be listed as the sponsor on the Australian Register of Therapeutic Goods (ARTG).

7. Prepare the Declaration of Conformity

• Declaration of Conformity: Draft a Declaration of Conformity stating that the device meets the Essential Principles and complies with relevant Australian and international standards. This document should be signed by an authorized representative of the manufacturer.

8. Fees and Payment Preparation

• Application Fees: Prepare for the application fee (approximately AUD 530 as of 2024) for listing the device on the ARTG. Additionally, there are annual charges (around AUD 1,080) once the device is registered.

• Budget for Regulatory Compliance Costs: Aside from TGA fees, factor in the cost of maintaining compliance, such as ISO certification, manufacturing audits, and post-market surveillance activities.

9. Post-Market Obligations Planning

• Post-Market Surveillance Plan: Develop a system for monitoring the device after it is on the market. This includes tracking complaints, reporting adverse events, and ensuring corrective actions are taken if any safety or performance issues arise.

• Prepare for Incident Reporting: Be ready to report any incidents or adverse events involving your device to the TGA through the Incident Reporting and Investigation Scheme (IRIS).

10. Advertising and Marketing Compliance

• Therapeutic Goods Advertising Code: Ensure that all promotional and advertising material complies with the Therapeutic Goods Advertising Code. Avoid making misleading claims about the device’s safety, performance, or regulatory status.

11. ARTG Listing Maintenance

• Understand ARTG Maintenance: After registration, you must ensure the device remains listed on the Australian Register of Therapeutic Goods (ARTG). This includes paying the annual charges and notifying the TGA of any significant changes to the device.

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