The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of medical devices and other healthcare products, has published guidance dedicated to the key performance aspects in the context of the applicable standards for medical/surgical face masks and respirators. The present document constitutes the initial version of the guidance and was initially published in December 2020. 

Regulatory Background

According to the current legislation, the Australian regulating authority conducts a post-market review of face masks placed on the market. At the same time, the TGA acknowledges the difference existing between various standards applied by the medical device manufacturers. The present document is intended to provide medical device manufacturers, sponsors, and also healthcare institutions and professionals with additional recommendations and clarifications regarding the standards to be applied, as well as to outline the applicable requirements on performance testing for respirators, surgical respirators, and medical/surgical face masks these devices should meet in order to be eligible for inclusion in the Australian Register of Therapeutic Goods (ARTG), the country’s national register of medical devices and other healthcare products allowed to be marketed and used in Australia. 

At the same time, the TGA mentions that the information provided in the guidance is not exhaustive. It should not be used as a compliance checklist. Moreover, the regulating authority reserves the right to update the guidance from time to time if it would be found necessary to reflect recent changes to the applicable regulations. 

In accordance with the present TGA guidance, face masks should be subject to regulation as medical devices in case if they are:

  • Intended to be used for the prevention of the transmission of disease between people, or 
  • Suitable for therapeutic use such as for surgical, clinical, medical use, or use in other health services. 

The face mask subject to review would be deemed as a medical device in case the labeling, advertising, or documentation provided by the manufacturer contains the claims listed hereabove. Consequently, such a face mask should be included in the ARTG in order to be allowed to be marketed and used in Australia. 

Under the general rule, any and all medical devices irrespectively of their class require conformity assessment evidence demonstrating that medical device is compliant with the Essential Principles addressing the most important aspects related to the design and safety of a medical device and confirming that the medical device meets the applicable safety and performance requirements. In particular, the TGA states that the intended purpose indicated by the manufacturer should be suitable, and the device itself should perform as intended. 

Thus, according to the applicable regulation, medical device manufacturers interested in placing their products on the Australian market shall have:

  • Appropriate conformity assessment procedures in place for the device; and
  • Appropriate documentation demonstrating compliance of the device with the Essential Principles. 

Applicable Standards

In order to demonstrate conformity with the Essential Principles, the medical device manufacturer may also refer to the applicable standards – the regulating authority additionally emphasizes that it recognizes certain standards to be used for this purpose, despite the fact that this is not a common way under the current legislation. 

According to the document, there are several types of standards medical device manufacturer may apply:

  • General standards, that could be applied for any device,
  • Device-specific standards applicable for the particular type of medical devices and outlining performance specifications,
  • Standards and procedures describing specific test methods related to specific performance criteria. 

The TGA states that when determining the particular standard to be applied, the medical device manufacturer shall consider the following aspects:

  • The intended purpose of the device,
  • The environment in which it is likely to be used,
  • The likely users of the device, and
  • The generally acknowledged state-of-the-art, or the level of development reached at any particular time usually as a result of modern methods. 

The guidance also contains a non-exhaustive list of standard medical device manufacturers may refer to when demonstrating compliance with the Essential Principles. At the same time, the TGA additionally emphasizes that the manufacturer is allowed to make such references only in case if the medical device in question meets any and all requirements set forth by the appropriate standard. The document additionally highlights the most important performance parameters to be considered. All applicable standards are divided into groups depending on typical intended purposes. For instance, the schedule provided in the TGA guidance includes, inter alia, the following details: 

Application of Testing Methods

The TGA describes in detail the way the manufacturer should determine the particular testing methods to be applied. For instance, the regulating authority outlines the criteria to be considered, namely: 

  • The intended purpose of the medical device in question,
  • The design of the medical device, including such aspects as construction, materials used, as well as the functions of each component of the device,
  • The results of any tests, including design calculations, risk analysis, investigations, technical tests.
  • The aspects related to post-market monitoring. 

The present TGA guidance also provides additional clarifications regarding the sampling plans as the approach to be used by the medical device manufacturer when determining the sample size and the acceptability criteria. The regulating authority emphasizes the use of solid statistical methods. According to the guidance, a sampling plan is the most important element of the approach for testing surgical face masks and respirators to ensure they are compliant with the applicable performance requirements. At the same time, the TGA states that there are some specifics the medical device manufacturer should pay attention to, namely:

  1. The sampling requirements set forth by different standards could be different as well, even if they are related to similar tests. 
  2. It is important to understand the context of the sampling plan and carry out a risk assessment before commencing the testing.
  3. Testing results should be provided not separately, but together with the details about other important aspects, such as the quality management system.

Summarizing the information provided here above, the present TGA guidance outlines the most important aspects to be considered in the case of surgical face masks and respirators. In particular, the document describes the applicable requirements, as well as the approach to be applied by the medical device manufacturers.

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