Medical Devices and In-Vitro Diagnostics are regulated in Australia by the Therapeutic Goods Administration (TGA), a division of the Australian Government’s Department of Health.
Medical devices are defined by section 41BD of the ‘Therapeutic Goods Act 1989’ and IVD devices are defined at the ’Therapeutic Goods (Medical Devices) Regulations 2002’.
Medical devices must be entered on the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in Australia, imported into Australia and/or exported from Australia.
Australian Sponsor Service
Manufacturers without a local office in Australia will need to work with an Australian Sponsor to submit applications, answer questions, and provide post market surveillance support.
With our Australian Sponsor service we will
• Verifying the documentation and the Technical File
• Register devices with TGA
• Represent the manufacturer in Australia
• Keep a copy of the Technical File for inspection by TGA
• Work with TGA for information upon request
• Inform the manufacturer of complaints and incidents
• Provide assistance for registration on TGA
TGA medical devices approve
A sponsor of a medical device must apply to the TGA to include their device on the Australian Register of Therapeutic Goods (ARTG). A sponsor is a person or company who is legally responsible for supplying a medicine or medical device. The TGA then applies a risk-based approach to assessing and approving a device for use in Australia. The TGA reviews the evidence at hand and request expert advice to determine whether the benefits of the device outweigh any possible risks.
Maintenance of conformity assessment
Once a device is approved, manufacturers are expected to continue to monitor the performance and safety of their devices and ensure continued compliance with the Essential Principles. This surveillance program is part of the quality management system aspect of their conformity assessment and will be periodically checked by the certifying body (whether this is the TGA or a European notified body). These surveillance programs should be appropriate to the intended purpose and risks of the device.
The data generated from safety and adverse event reports and complaints, newly identified risks, literature, any updated or new clinical investigations, significant regulatory actions and formal surveillance activities such as registries should be used by the manufacturer to review the performance, safety and benefit-risk assessment of the device.
TGA post-market vigilance and monitoring
The medical device regulatory framework includes provision for post-market monitoring by the TGA, including:
• risk assessment and investigation of medical device adverse event and complaint reports
• checking evidence of conformity against the Essential Principles
• conducting periodic inspections of manufacturers‘ quality management systems and technical documentation
• imposing specific requirements for manufacturers and sponsors to report, within specified timeframes,
adverse incidents and other information involving their medical devices.
Post-market monitoring by the TGA is carried out to ensure the ongoing regulatory compliance and safety of medical devices supplied to the Australian market.
In support of the TGA’s post-market monitoring activities, the sponsor of a medical device has ongoing responsibilities once a device has been included in the ARTG.
These statutory responsibilities include that the sponsor must report to the TGA:
• adverse incidents
• overseas regulatory actions
• the results of investigations undertaken by the manufacturer, such as further clinical studies and reviews of adverse events.
The sponsor must also obtain requested information from the manufacturer and maintain distribution records.
All adverse event reports or complaints received by the TGA are entered into a database, and a risk assessment undertaken by a panel of clinicians and scientists within the TGA to determine if investigation is required. Expert advice may be sought during an investigation.
The outcomes of TGA’s investigations may result in:
• product recovery (recalls)
• hazard and safety alerts
• product modification/improvement by a manufacturer
• surveillance audits of manufacturing sites.