Medical Device Registration Process-Australia

Medical Device Registration Process – Australia

In Australia the agency that regulates all medical devices is called Therapeutic Goods Administration (TGA).

As per Therapeutic Goods Act 1989, medical devices are defined as any of the following items for human use:

• Instrument
• Apparatus
• Appliance
• Software
• Implant
• Reagent
• Material or other article.

This article provides a comprehensive guide on the requirements and steps involved in registering a medical device in the Australian market. Medical devices imported into, supplied in, or exported from Australia must be included in the Australian Register of Therapeutic Goods (ARTG). This needs to be done by the device's Australian sponsor, similar to a Legal or Authorized representative.

All medical devices included in the ARTG must comply with the essential principles, and their manufacturers must apply conformity assessment procedures (or requirements comparable to conformity assessment procedures) that are appropriate to the kind of device.

Basic Requirements for Registration

• Companies without an established place of business in Australia must appoint an in-country representative, known as an Australian Sponsor. The Australian Sponsor is responsible for device registration (ARTG listing) and post-market activities, such as adverse incident reporting and recalls. The Australian sponsor's name and contact information must appear on the device and the device label.
• Medical device sponsors must have their product in the ARTG unless the product is exempt or excluded.
• To register a medical device in Australia without any CE Marking, it must undergo a TGA conformity assessment, which is essentially equivalent to an EU Notified Body assessment to obtain CE marking certification.
• Any manufacturer, sponsor, or agent who wants to use online services will need a client identification number (Client ID) and also need to apply to access online TGA Business Services (TBS).

Medical Device Registration Process in Australia 

1. Conformity Assessment — Compliance documentation and quality system evaluation
2. Appoint Australian Sponsor — Designate a responsible entity for submission
3. Submit Device — Complete application and provide necessary documents
4. Pay Fees — Payment of evaluation and application fees
5. Device Evaluation — Review of technical files and clinical data

The registration process with the TGA involves the following key steps:

1. Classify the Medical Device

Medical devices will be placed into one of the main classifications depending on the level of risk they pose. The requirements for registration are proportional to the risk associated with the device. Devices are classified by considering a number of different parameters, such as:

• Intended use of the Medical device.
• Invasiveness of the device (e.g., is it a bandage to be placed on the skin or a catheter to be inserted into the body)
• Part of the body where the device will be used.
• Duration of the medical device in the body.

Classification Table:

2. Conformity Assessment

Medical device manufacturers (including IVDs) require:

• Appropriate documentation demonstrating compliance of the device with the Essential Principles.
• For class 1 IVD and class I medical device manufacturers, a Declaration of Conformity (DoC).
• Higher-class medical device (Class Is, Class IIa, IIb, III) manufacturers need an appropriately certified quality management system.
• Higher-class medical device manufacturers need either a TGA-issued conformity assessment certificate or conformity assessment documents from a comparable overseas regulator.

3. Appointing an Australian Sponsor

• The manufacturer must appoint an Australian Sponsor, who takes responsibility for submitting the application and ensuring compliance.
• Sponsors must be an Australian resident or company.

4. Submitting the Device

• The sponsor applies to include the device in the Australian Register of Therapeutic Goods (ARTG).
• The application involves:
  • Completing the online form through the TGA Business Services portal.
  • Providing necessary documentation (e.g., technical files, conformity assessment certificates, and device description).

5. Pay the Fees

• The fee depends on the classification of the device.
• Sponsors must pay evaluation and application fees based on the device class and review type.

6. Evaluation of the Device

• The submitted application and documents shall be reviewed by the TGA.
• For higher-risk devices, the evaluation includes:
  • Technical File review
  • Clinical evaluation assessment
  • Testings and other relevant documents review

7. APPROVAL OF THE DEVICE

• Once approved, the device is included in the ARTG and can legally be supplied in Australia.
• The ARTG entry includes details like the product name, sponsor, and classification.

8. Post-market Requirements

Until the device is in the ARTG, the following requirements must be fulfilled:

• Adverse Event Reporting: Report any device-related adverse events (malfunctions, injuries, deaths) to the TGA within specified timeframes.
• Corrective Actions and Recalls: Address safety issues through corrective actions, recalls, or updates, and follow the TGA's recall procedures.
• Post-Market Monitoring: Continuously evaluate the device's safety and performance, manage complaints, and submit safety update reports for high-risk devices.
• Notify Changes: Inform the TGA of significant changes to the device, its manufacturing process, or associated evidence.