Personal Protective Equipment (PPE) Regulation as a Medical Device by the TGA
Due to the COVID-19 pandemic, the demand for PPE has significantly increased. In response to the greater demand, the TGA has issued guidance on the regulation of face masks, gloves and gowns. The regulation is dependent on the product type and its therapeutic purpose.
What is PPE?
PPE refers to clothing and equipment (face masks, gloves and gowns) used to protect an individual against one or more health and safety hazards.
When is PPE considered a medical device?
The regulation defines PPE as 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 the 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. Therapeutic Goods (Medical Devices – Specified Articles) Instrument 2020)
Bearing this in mind, non-sterile PPE i.e. safety glasses, masks, gloves etc. which are presented as or make the claim to be used in the prevention of transmission of disease between people, are medical devices. This determination is made based on the information (i.e. intended use) provided on the labelling, instructions for use (IFU), packaging, etc.
How will these be classified?
PPE which meets the definition of a medical device will most likely be classified as one of the following;
- a Class I medical device;
- a Class Is (sterile) medical device; or
- a Class IIa medical device.
How does the manufacturer demonstrate compliance with the regulations?
For PPE which is manufactured or supplied to the Australian market and is considered a medical device, the manufacturer should ensure that they have a:
- appropriate conformity assessment procedures in place for the device; and
- appropriate documentation demonstrating compliance of the device with the Essential Principles.
Any product that meets the definition of a medical device and is intended to be supplied in Australia, must be included on the Australian Register of Therapeutic Goods (ARTG) prior to supply.
If the manufacturer is based outside of Australia, they must appoint an Australian based sponsor for the medical device. The sponsor of a medical device is the legal entity responsible for the importation and/or supply of the device within Australia.
After inclusion on the ARTG, what is the manufacturer required to do?
- Ensure advertising for the device is compliant with the Therapeutic Goods Advertising Code.
- Keep distribution records
- Report adverse events
- Ensure the device continues to meet all relevant regulatory requirements.
For effective and compliant supply of PPE to the Australian market, it is necessary for the manufacturer to be proactive and determine if your product is a medical device. KD&A can help you determine if your PPE product is a medical device and guide your organisation with demonstrating TGA regulatory compliance throughout the product lifecycle.
TGA Medical Device Class I Update – Changes to the Australian Register of Therapeutic Good (ARTG) inclusion process for non-measuring, non-sterile Class I medical devices
November 9, 2020
June 4, 2020