The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published the updated guidelines on the risk management approach to be applied with regard to medicines and medical devices. The document provides a general overview of the applicable regulatory requirements and highlights the most important aspects to be considered by the medical device manufacturers and other parties involved.

Regulatory Background 

The TGA outlines the activities it conducts to ensure the safety and effectiveness of any and all medical devices allowed to be marketed and used in Australia. These activities include the following ones:

  • The initial pre-market review and assessment conducted on the basis of the appropriate request of an interested party before granting the permission to place a medical device on the Australian market;
  • Continuous post-market monitoring and surveillance;
  • Granting establishment licenses to domestic medical device manufacturers, as well as ensuring that the foreign ones achieve and sustain compliance with the applicable regulatory requirements;
  • Ongoing supervision and surveillance, including necessary regulatory actions to be taken to address potential violations.

According to the guidelines, the current regulatory approach is based on the best practices adopted in foreign countries with regard to the safety and quality of medical devices, as well as risk management procedures. The TGA also takes into consideration the recommendations developed by the International Medical Device Regulators Forum (IMDRF), a voluntary association of the national regulating authorities collaborating for the further development and improvement of the regulatory requirements and general principles to be applied for medical devices. 

The TGA also states that any and all medical devices intended to be placed on the Australian market should comply with the Essential Principles, while the particular regulatory requirements to be applied when assessing compliance of a medical device would depend on its intended purpose initially indicated by the medical device manufacturer, and also on the class of the medical device in question under the risk-based classification. 

Monitoring and Surveillance 

The TGA states that the responsibilities in the sphere of post-market surveillance and monitoring should be actually shared among all the parties involved including medical device manufacturers, sponsors, healthcare providers, and customers actually using medical devices. According to the applicable regulatory requirements, each of the aforementioned parties has its own obligations and responsibilities related to the incidents and actions to be taken to reduce hazards associated thereto and mitigate the consequences. These responsibilities include, inter alia, the following ones:

  • Collecting information about medical devices from healthcare professionals and customers using them,
  • Notifying the regulating authority about incidents associated with medical devices,
  • Demonstrating compliance with the applicable conformity assessment procedures,
  • Adverse event reporting, 
  • Applying exemption rules. 

Thus, the post-market activities include a variety of actions to be performed in order to ensure ongoing conformity of medical devices placed on the Australian market with the applicable regulatory requirements set forth under the current framework. Simultaneously, the regulating authority itself implements special measures to be applied to monitor the safety and effectiveness of medical devices allowed to be marketed and used. 

The TGA additionally emphasizes the importance of consultations as one of the main forms of cooperation between the regulating authority and industry representatives. For this purpose, the TGA has already introduced the appropriate stakeholder engagement framework. The authority states that such collaboration should cover both internal and external stakeholders. 

Post-Market Reviews of Medical Devices 

It is also important to mention that all the aspects related to the post-market review of medical devices are described in detail in the appropriate guidance issued by the TGA earlier in October 2020. The document highlights the most important regulatory requirements and outlines the responsibilities of all the parties involved. 

According to the document, the TGA performs post-market reviews to ensure the ongoing compliance of the medical devices placed on the Australian market with the applicable regulatory requirements. For this purpose, the authority selects a medical device from the list of approved products contained in the country’s national register of healthcare products – the Australian Register of Therapeutic Goods (ARTG). 

The reasons for choosing the particular medical device for the post-market review include the following ones: 

  • The significant and/or increasing number of incidents and adverse events associated with the medical devices, 
  • Safety-related warnings and similar information received from the foreign regulating authorities, as well as the information about special actions taken in this regard,
  • Identifications of the issues of any nature for a similar product,
  • Pending recalls,
  • Information collected from the review of clinical evidence. 

The TGA emphasizes that any and all medical devices could be subject to review irrespectively of their class under the risk-based classification. Such a review could be aimed at any step of the device`s lifecycle. 

Should the regulating authority choose a particular medical device for review, it would duly notify its manufacturer and/or its authorized representative. In particular, there would be a letter issued by the TGA, outlining the scope of information to be provided by the entity responsible for the medical device subject to review. The letter would also contain the indication of a timeframe within which the response should be provided to the regulating authority. Should the responsible entity fail to provide the requested information in time, the TGA is entitled to initiate an exclusion of the medical device in question from the national register of healthcare products that automatically result in the prohibition of its marketing in Australia. To avoid this, the responsible entity shall duly notify the TGA in advance about any issues related to the provision of the information requested that could result in a delay in response. In such cases, the regulating authority may agree to extend the response timeframe. It is also important to mention that the ones providing incorrect information to the TGA could face the sanctions prescribed by the applicable civil and criminal legislation. 

The way the response should be provided would be described in the request itself, including the documents to be submitted. As usual, the response should be provided in electronic form. In most of the cases, the request described herein includes the requirement to provide additional information, documents, or samples of medical devices subject to review or, in certain cases, a proposal to suspend or withdraw the registration of a medical device in the national register. 

Upon receipt of the response provided by the responsible entity, the TGA would review it and inform whether any actions are still to be taken. Depending on the response, the regulating authority may request additional information, required to conduct certain actions, or consider the case closed and the review completed. Should the additional actions still be needed, the TGA would collaborate closely with the responsible entity to ensure that all the necessary measures have been duly taken. 

Summarizing the information provided here above, the TGA has published additional recommendations and clarifications related to the approach to be applied to ensure the ongoing safety and effectiveness of the medical devices allowed to be marketed and used in Australia. The regulating authority also describes the regulatory requirements related to post-market surveillance and additional measures to be applied in this regard.

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