September 24, 2021
A Glimpse of TGA’s Overhaul of Medical Device Regulations

Therapeutic Goods Administration (TGA), under the ‘Therapeutic Goods Act 1989,’ is entitled to regulate medical devices placed and marketed in Australia. Medical devices are regulated under the Therapeutic Goods (Medical Devices) Regulations, 2002. Initially introduced in 2002, the regulations underwent multiple amendments at a frequency of at least once a year, almost every year. Though these amendments introduced changes to accommodate the industry trends, a huge divide still exists between the industry and the regulations, triggering a major TGA medical device reform.  

The main objective of the Australian medical device reforms is to enhance patient safety and to ensure that medical devices of higher quality, performance, and safety are available for patient access. In December 2020, the TGA came up with medical device reforms and had drafted an action plan. The TGA intends to strategically implement the reforms to tighten the Regulatory scrutiny at the following three (03) possible phases of a device life cycle:

·Strategy 1 - To improve how new devices get on the market

·Strategy 2 - To strengthen monitoring and following-up of devices already in use

·Strategy 3 – To provide more information to patients about the devices they use

 

Improving the Process of How New Devices Get on the Market

TGA has already implemented certain initiatives like Priority review pathway for medical devices, Alignment of medical device Regulatory framework with the European Union (EU), Comparable overseas regulators, etc. The other reforms related to the Australian Conformity Assessment Bodies (Australian CAB) are still in the developmental stage.  

TGA Strategy 1 Initiatives

Description

Priority review pathway for medical devices

To expedite the assessment of certain medical devices under priority review.

Establishment of the Australian CAB

Australian corporations can apply for the Australian CAB determination and issue conformity assessment certification for medical devices.

Reviewing the regulation of low-risk products

Appropriate regulation of low-risk devices to improve consumer safety, reduce Regulatory burden and improve Regulatory knowledge.

Changes to the regulation of Personalized Medical Devices (PMD)

A new framework was introduced to ensure the appropriate level of regulation of PMD to manage the risk these devices may pose.

Reviewing the regulation of self-testing IVDs

To ensure that all IVDs are subject to an appropriate level of premarket scrutiny prior to the supply in Australia.

Changes to the regulation of IVD Companion diagnostics

To harmonize with other jurisdictions to ensure that all IVDs are subject to premarket scrutiny prior to the supply in Australia.

Changes to the regulation of medical device software

To regulate software-based medical devices, including software that functions as a medical device in its own right.

Reclassification of certain medical devices

The TGA is reconsidering the current classification of devices where safety issues have been identified and/or the European Union has changed its classification systems.

 

Harmonization of the Australian classification rules safeguards patients to harmonize the requirements, facilitate the market's smooth operation, and ensure timely access to medical devices.

Benchmarking against the International assessment timeframes

The Review of Medicines and Medical Device Regulations identified that TGA's conformity assessment timeframes should be reviewed after benchmarking with comparable overseas regulators.

Mutual Recognition Agreement (MRA) changes

Between Australia and the European Community, provision for the mutual acceptance of conformity assessment for medical devices.

Acceptance of comparable overseas Regulatory approvals in Australia

Marketing approvals and certificates from comparable overseas regulators can be considered for TGA approvals and enable medical devices to be available for patients in Australia sooner.

 

Strengthening Post-market Monitoring and Following-up of Devices in Use

The TGA has made reforms like the Establishment of a Unique Device Identification System, which will enable TGA to trace the medical device for clinical or Regulatory action if any issue with device safety is identified. A reform to enhance post-market monitoring is also released. A new overhaul called the reviews of devices of concern has been released for class III devices, requiring higher evidentiary requirements.

Reviews of Devices of Concern

 

Establishment of a Unique Device Identification

 

Enhancements to Post-market Monitoring

 

 

 

 

 

  • All new applications for surgical mesh devices must meet higher evidentiary requirements of a Class III medical device system

 

  • The Australian Government has allotted a budget for FY 20-21 for establishing Unique Device Identification (UDI) database for medical devices.
  • The TGA will administer the UDI database
  • One can use the information to support tracking and tracing of medical devices
  • To enable timely clinical and Regulatory actions in case of medical device safety issues.

 

  • The TGA reporting forms improve monitoring and tracking of device incident reports, following feedback from stakeholders.
  • A report can be lodged electronically
  • Previously reported incidents, initial reports, and follow-up reports could be updated.
  • The status of reports can be reviewed, and past reports can be viewed.

 

Consumer Awareness About the Devices They Use

TGA intends to empower the consumer by providing more information to patients about the devices they use. TGA also is planning to establish an expert group with consumer representation.

The TGA has developed an exceptional action plan for the medical devices entering the Australian market with strong research and analysis. With these medical device reforms, the approval process in Australia has become more stringent and systematic that ensure complete patient safety. For more information on medical device reforms in Australia, consult a Regulatory expert like Freyr.

Stay informed. Stay compliant.