Registering Class IIa medical devices with the Australian Therapeutic Goods Administration (TGA) involves a multi-step process designed to ensure that the devices are safe, effective, and meet Australian regulatory requirements. Below is a comprehensive guide covering the process, required materials, and key considerations for registering Class IIa medical devices with the TGA.

1. Process for Registering Class IIa Medical Devices with the TGA

Step 1: Classify the Device

• Ensure that your medical device falls under the Class IIa category.
  • Class IIa devices are medium-risk devices with a moderate level of interaction with the human body (e.g., dental materials, surgical gloves).
  • Classification is based on the intended use, risk level, and duration of contact with the human body.

Step 2: Appoint an Australian Sponsor

• If you are an overseas manufacturer, you must appoint an Australian sponsor. The sponsor is legally responsible for the device in Australia and will handle the application on your behalf.
• The sponsor must be an Australian resident or an entity with a registered office in Australia.

Step 3: Compile Technical Documentation

• Prepare the technical documentation that proves your device meets Australian regulations and Essential Principles of safety and performance (similar to EU regulations).
• This documentation must include:
  • Device description.
  • Risk management information.
  • Clinical evidence.
  • Manufacturing details.
  • Labeling and instructions for use (IFU).

Step 4: Obtain Conformity Assessment

• Conformity assessment ensures the device meets the necessary regulatory requirements.
  • If your device already has overseas certification (e.g., CE mark from the EU), the TGA will often accept this as evidence of conformity, simplifying the process.
  • If the device lacks such certification, you will need to undergo a TGA conformity assessment, which includes reviewing the quality management system (QMS) and technical documentation.

Step 5: Submit the Application via TGA Business Services Portal

• The application is submitted via the TGA Business Services (TBS) portal.
  • You must upload the necessary documents, provide details about the device (e.g., Global Medical Device Nomenclature (GMDN) code, intended use), and submit evidence of conformity assessment.
  • Pay the required application fee.

Step 6: TGA Review and Assessment

• The TGA will review the submitted documentation to ensure compliance with Australian regulations.
  • If the device is already certified by an overseas authority, the TGA will usually conduct a streamlined review.
  • If additional evaluation is required (such as a detailed technical assessment), this may extend the review period.

Step 7: ARTG Inclusion

• Upon successful review, the device will be included in the Australian Register of Therapeutic Goods (ARTG), allowing it to be legally marketed in Australia.
  • The sponsor will receive a certificate confirming ARTG inclusion.

Step 8: Post-Market Obligations

• After the device is registered, the sponsor must ensure ongoing compliance with post-market regulations, including:
  • Monitoring adverse events and reporting any safety issues to the TGA.
  • Implementing post-market surveillance to ensure ongoing safety.
  • Maintaining records and reporting any significant changes to the device.

2. Required Materials for Class IIa Medical Device Registration

To register a Class IIa medical device, you will need to prepare and submit the following materials:

a. Technical Documentation

• A comprehensive technical file that includes:
  • Device Description: Detailed information about the device, including its intended use, design, and function.
  • Risk Management File: Risk assessment documents demonstrating compliance with ISO 14971 (Risk Management for Medical Devices).
  • Clinical Evaluation Report (CER): Clinical data proving the device's safety and performance.
  • Verification and Validation Data: Results of performance testing, safety evaluations, and any other verification methods.
  • Labeling and IFU: The device’s labeling, packaging, and instructions for use must be clear and comply with regulatory standards.

b. Manufacturer’s Evidence

• If the device is certified by an overseas regulatory authority (e.g., the CE mark from the EU), provide conformity assessment certificates or manufacturer’s evidence to demonstrate compliance with international standards.

c. Quality Management System (QMS) Certification

• A copy of the manufacturer’s ISO 13485 certificate (or equivalent QMS certification) is typically required to demonstrate that the manufacturing process meets quality standards.

d. Essential Principles Checklist

• A checklist showing how the device complies with the Essential Principles of safety and performance as required by the TGA. These principles cover aspects such as:
  • Safety.
  • Performance.
  • Risk management.
  • Clinical evaluation.
  • Labeling.

e. GMDN Code

• A valid Global Medical Device Nomenclature (GMDN) code for the device, which is used to classify medical devices.

3. Considerations for Registering Class IIa Devices

a. Use of Overseas Certification

• If the device has already been certified by an overseas regulatory body (e.g., CE mark), the process with the TGA may be faster and less costly, as the TGA often accepts such certifications as evidence of conformity.
• Ensure that the overseas certification is still valid and covers all aspects of the device’s intended use in Australia.

b. Post-Market Surveillance and Vigilance

• After ARTG inclusion, the sponsor must comply with the TGA’s post-market surveillance requirements. This includes monitoring adverse events and ensuring that the device continues to meet safety standards.
• Sponsors must report adverse events, malfunctions, and product recalls to the TGA.

c. Fees and Timeframes

• The costs for application, conformity assessment (if required), and annual ARTG charges must be factored into the process. Fees for Class IIa devices typically include:
  • Application fee: AUD 1,000 to AUD 1,500.
  • Conformity assessment fee: AUD 10,000 to AUD 20,000 if the device requires a TGA conformity assessment.
  • Annual ARTG charges: AUD 800 to AUD 1,100 per year.
• Timeframes: Registration can take between 3 to 12 months, depending on whether the device has prior certification and the complexity of the application.

d. Keep Documentation Up to Date

• All technical documentation and records must be kept up to date to ensure compliance, especially if the device undergoes design changes or if there are updates in regulatory standards.

Summary: Key Steps and Materials

• Process:

  1. Classify the device.
  2. Appoint an Australian sponsor.
  3. Obtain conformity assessment.
  4. Submit the application via the TGA Business Services portal.
  5. Pay application fees.
  6. TGA review and ARTG inclusion.
  7. Post-market surveillance.

• Required Materials:

  • Technical documentation (including device description, risk management, clinical data).
  • Manufacturer’s evidence (e.g., CE mark).
  • QMS certification.
  • Essential Principles checklist.
  • GMDN code.

By following the outlined process and ensuring all documentation is in order, manufacturers and sponsors can successfully register Class IIa medical devices with the Australian TGA.

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