PPE Regulation & COVID 19

With the current pandemic the TGA (Therapuetic Goods Administration) has made concessions on the supply of certain goods. Specifically, medical devices designed to be worn by people to prevent the transmission of organisms (Personal Protective Equipment – PPE) are exempt from compliance and registration requirements conditional on:

  • This supply must be under contract with the Department of Health or other Department acting on their behalf.
  • Records are kept of the supply
  • Only until the 31st January 2021

Other PPE may require TGA registration. Please see here and here for details but in summary:

  • Face masks and gowns which are non-sterile and designed as safety or protective apparel for use in the home or for recreational use are excluded from regulation by the TGA under the Act.
  • Face masks or gowns which are presented or claimed to be for therapeutic use, such as being labelled for surgical use, or to reduce or prevent the transmission of disease or micro-organisms such as bacteria or viruses, meet the definition of a medical device and are regulated by the TGA under the Act.

This includes:

  • Protective eyewear such as goggles, glasses or visors
  • Disposable face masks
  • Disposable gloves
  • Disposable gowns

DTS can help you register these products on the Australian Register of Therapeutic Goods (ARTG).

Fees

Our consulting fees to help you include your products on the ARTG will be dependent on the class of device and the availability of the required evidence to support a medical device application.

Time frames

Although the TGA are currently working to prioritise applications for devices that are required to manage the corona virus pandemic, they do not provide statutory time frames for processing applications. Additionally, there are other aspects of the process which we do not have control over and cannot predict how long they may take. This includes whether or not we first need to apply to have the manufacturer added to the TGA database if not already listed (this can take a up to a couple of days); if there are any deficiencies in the certifications/data; and whether there are any hold-ups in obtaining the manufacturer’s declaration of conformity from the manufacturer (this is a specific TGA template that will be provided to you once we commence work).

However, it is reasonable to plan for 2- 4 weeks in the current climate provided there are no major deficiencies and hold-ups.