The Therapeutic Goods Administration (TGA) of Australia has published detailed guidelines dedicated to the regulation of Personal Protective Equipment (PPE) in the context of the outbreak of COVID-19.
These devices are facing a significant increase in demand during the pandemic, so the TGA intended to ensure and expand their availability to meet existing needs. The present guidelines are intended to:
- provide general information about the regulatory approach,
- inform the medical device manufacturers regarding the applicable requirements,
- describe the procedures to be followed in order to include medical devices in the Australian Register of Therapeutic Goods (ARTG), the country’s national register of medicines and medical devices, and also to
- provide additional information that is important for healthcare professionals and other customers using the personal protective equipment.
The present TGA guidance on personal protective equipment provides an overview of the applicable legislation and regulatory requirements related to the PPE. The guidelines are based on the provisions of the following regulations:
- Therapeutic Goods (Excluded Goods) Determination 2018,
- Therapeutic Goods (Medical Devices – Specified Articles) Instrument 2020,
- Therapeutic Goods Act 1989.
The provisions of the aforementioned regulations outline the scope of personal protective equipment subject to regulation, eligibility criteria, and also the safety and performance requirements to be applied.
For instance, in accordance with the Therapeutic Goods (Medical Devices – Specified Articles) Instrument 2020, the products subject to regulation as medical devices include articles that are non-sterile personal protective equipment or safety apparel (including but not limited to aprons, face masks, gloves, goggles, gowns, and visors) intended, by the person under whose name the articles are or are to be supplied, to be used for prevention of the transmission of disease between persons, including where that intention may be ascertained from the articles being represented as suitable for use in surgery, or clinical, medical or other health services. Consequently, non-sterile personal protective equipment is subject to regulation as medical devices. Hence, the provisions of the Therapeutic Goods Act 1989 should be applied, and the TGA as the national regulating authority is entitled to conduct the genera oversight and surveillance with regard to such products. Moreover, such products are subject to mandatory inclusion in the national register of regulated healthcare products, the ARTG, in order to be allowed for marketing and use in Australia.
The TGA also states that its position regarding the intended use of medical devices would be based on the information about the intended use of the PPE indicated by its manufacturer in the labeling and documentation accompanying the product. If the claims made by the manufacturer would contain the statements regarding the suitability of the product for use in the context of clinical, medical, or other health services, the regulating authority would treat the product as a medical device. At the same time, in certain cases, the TGA could make the same determination even if there are no such claims in the labeling or other documentation.
Under the general rule, personal protective equipment that falls within the scope of the definition of a medical device could be regulated as either:
- Class I medical device,
- Class Is (sterile) medical device, or
- Class IIa medical device.
According to the present TGA guidance, non-sterile personal protective equipment or safety apparel … that is not presented to be, or claimed to be, for use for prevention of transmission of disease between people is not a therapeutic good. Hence, such products are not subject to mandatory inclusion in the national register.
Personal Protective Equipment: Manufacturing Requirements
The TGA states that PPE subject to regulation as the medical device should meet any and all applicable requirements set forth by:
- The Therapeutic Goods Act 1989,
- The Therapeutic Goods (Medical Devices) Regulations 2002, and
- The Therapeutic Goods Regulations 1990.
In particular, the appropriate conformity assessment is required for medical devices irrespectively of their classification. Such a conformity assessment is intended to ensure that the medical device subject to review complies with the applicable requirements set forth by the Essential Principles, including the ones related to the design and construction of a medical device. These requirements cover the most important aspects related to the safety and correct performance of a medical device when used for the intended purpose.
According to the TGA guidance on personal protective equipment, all medical devices intended to be placed 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.
The TGA also mentions that the medical device manufacturer may demonstrate compliance with the Essential Principles by making references to the applicable standards. Actually, this approach is not common under the current Australian regulatory framework, but certain standards are recognized by the TGA and could be used to demonstrate the conformity of the medical device in question. The particular standards to be applied would depend on the intended purpose of the device, the environment it is intended to be used (e.g. clinical environment), the current state-of-the-art, and also the expected users (laypersons or healthcare professionals).
The Australian regulating authority emphasizes that the applications submitted by the US-based medical device manufacturers would be prioritized, while the international applications would have lower priority.
The TGA guidance on personal protective equipment additionally clarifies certain device-specific requirements to be applied for the particular types of personal protective equipment, including surgical masks and respirators, surgical gowns, surgical gloves, goggles, and visors. For instance, according to the guidance, the labeling “N95” could be used only in case of NIOSH-approved devices, or case there is sufficient evidence in place confirming compliance of the device with the requirements set forth under 42 CFR Part 84, providing that the appropriate testing has been performed by the accredited laboratory. It is stated that in order to be allowed to use the labeling “N95” the medical device manufacturer shall have the evidence confirming that the respirator meets the 95% filtration criterion. Moreover, the aforementioned requirements could be used for both respirators subject to regulation as medical devices and ones that are not medical devices.
The TGA mentions that it has already commenced a broad post-market review of filtering facepiece respirators and facemasks marketed in Australia in order to assess their compliance with the applicable performance requirements.
The guidance also provides the list of standards to be applied in the case of surgical gowns and gloves. The list includes international (ISO, ASTM) and national (AS/NZS) standards the medical device manufacturers may refer to when demonstrating compliance with the applicable requirements.
The TGA provides additional clarifications regarding the various types of protective equipment, the ways they could be used, as well as the limitations associated thereto. For example, the authority states that utility masks do not create sufficient protection and thus could not be used for such purposes. These products are not medical devices.
Summarizing the information provided here above, the TGA guidelines on personal protective equipment are intended to provide medical device manufacturers with additional recommendations and clarifications regarding the applicable requirements set forth under the Australian legislation. The TGA outlines the particular requirements the personal protective equipment should meet, and also the ways compliance could be demonstrated.
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