How to Import Face Masks and Protective Equipment into Australia During COVID-19

Below, we’ve developed a handy guide about importing face masks and personal protective equipment (PPE’s) into Australia amidst the COVID-19 pandemic. We’ll outline the current state of the ‘face mask market’, the relevant rules and regulations, how to register your imports and also give you a run-down on what’s prohibited.

Face Masks and PPE: The New Market

Ever since the Coronavirus pandemic, the surge in demand for protective equipment like face masks, hand sanitiser and tissues has risen dramatically. This is especially the case in Victoria, where Stage 4 lockdown restrictions have introduced mandatory rules regarding the use of face masks.

In July 2020, Priceline reported a 30-fold rise in mask sales, whilst Bunnings have also announced a limit on the number of masks that customers can purchase. Med-Con, a medical consumables company based in Shepparton, Victoria, are currently producing up to 3 million medical masks every week. They’ve admitted that they “physically cannot make any more masks” to meet rising demand in Victoria.

It’s even been reported that some companies are ‘price gouging’, charging unusually high prices for goods that would otherwise cost much less. Reports have emerged that one store owner purchased boxes of face masks at $11 per pace mask, then on-sold them for $200 each. One chemist in Sydney was also caught selling a box of 50 face masks for $399.99.

You may be wanting to sell face masks to take advantage of this new market, but you must be aware of the rules in place when deciding to import them.

personal protective equipment PPE's

Importing Face Masks and PPE: The Rules

The regulations differ between certain types of equipment, including between medically certified face masks and masks for recreational use.

Face Masks

face-masks-import

The Therapeutic Goods (Declared Goods) Order 2019 declares specific goods and specific classes of goods to be ‘therapeutic goods’ for the purposes of therapeutics legislation. Further, the Therapeutic Goods (Medical Devices-Specified Articles) Instrument 2020 also specifies particular goods to be ‘medical devices’.

Face masks that are presented to be, or claim to be, for use for the prevention of the transmission of disease between people are ‘medical devices’. They are therefore regulated by the Therapeutic Goods Act 1989 and will need to be placed on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied.

Information held on the ARTG will include the name of the product, its formulation details as well as the company (known as the ‘sponsor’) and manufacturer details. The ARTG is in the public realm and can be searched through the Therapeutic Goods Administration’s website.

Sterile face masks claimed to be used in a clinical setting are classified as Class I (sterile) medical devices. This means that there is no public health risk or a low personal risk.

Note, however, that masks that are non-sterile and designed as safety or protective apparel for use in the home or for recreational or occupational use are excluded from regulation by the Act and don’t need to be registered.

Normal Duty: 5% of AUD$ FOB price (Free under CHAFTA and most other Free Trade Agreements)

GST: 10% of the AUD$ CIF plus duty amount

Hand sanitisers

applaying hand sanitizer

Hand sanitisers are classified as ‘general consumer products’ (cosmetics) or therapeutic goods depending on their contents and what effects they claim to have. Products making claims about COVID-19 are not cosmetics.

Different claims with regards to hand sanitisers that indicate therapeutic use include claims such as:

  • ‘for use in clinics and hospitals’;
  • ‘effective against viruses’; and
  • ‘helps to reduce the transmission of COVID-19’.

These types of hand sanitisers must be included in the ARTG unless an exemption applies. One of these exemptions, as indicated above, includes if they are cosmetics.

Hand sanitisers will also be excluded from the registration requirement if they meet certain formulation, manufacturing, labelling and advertising requirements specified in the Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020. You can read more about these requirements on the TGA’s website.

Normal Duty: 5% of AUD$ FOB price (Free under CHAFTA and most other Free Trade Agreements)

GST: 10% of the AUD$ CIF plus duty amount

Gloves, Goggles, Gowns and PPE

Gloves, Goggles, Gowns medical PPE

The regulation of various pieces of PPE by the TGA is also very strict, and importers must be aware of the rules surrounding their entry into Australia.

Similarly, with face masks, gloves, goggles, gowns and visors that are presented to be, or claim to be, for use for the prevention of the transmission of disease between people are “medical devices” and must be registered on the ARTG before they can be supplied.

Normal Duty: 5% of AUD$ FOB price (Free under CHAFTA and most other Free Trade Agreements)

GST: 10% of the AUD$ CIF plus duty amount

You can find further information in our comprehensive guide on importing hygiene items and protective gear.

How to register your medical device on the Australian Register of Therapeutic Goods (ARTG)

The ARTG is the primary point of regulation for the lawful supply of therapeutic goods throughout Australia. If you are a ‘sponsor’ of a medical device, then you take complete responsibility for that particular supply into Australia.

  • Review the Guidelines. The first thing you’ll need to do is review the Australian Regulatory Guidelines for Medical Devices. These are guidelines published by the Therapeutic Goods Administration (TGA) and provide a range of information on importing and exporting medical devices within Australia, as well as the relevant law.
  • Apply for a Client ID with the TGA. A Client ID will allow you to supply therapeutic goods and import therapeutic goods into Australia. To apply, you’ll need to complete the Organisation details form and submit it to the TGA Business Services HelpDesk.
  • Apply for a TGA Business Services Account. This account will allow you to access the online business services and manage therapeutic good registration applications. You’ll need a Client ID to access this account.
  • Follow the TGA’s inclusion process guidelines. This includes information about factors to consider before submitting your application and whether your product is actually a ‘medical device’.
  • Pay the fees. You’ll need to pay a fee to register your medical device on the ARTG, as the TGA must recover its costs through fees and charges for all the activities undertaken. The fees differ depending on the medical device registered – for example, applying for a Class I (sterile) medical device (such as face masks) to be included on the ARTG costs $1,060.00 (at the time of writing).

Know the Prohibited Exports

Prohibited medical PPE Exports covid-19

If you’re in the business of importing and exporting goods, you should be aware of the new restrictions imposed on certain exports in response to COVID-19.

These include:

  • disposable face masks
  • disposable gloves
  • disposable gowns;
  • goggles, glasses or eye visors;
  • alcohol wipes; and
  • hand sanitiser.

There are range of exceptions to these restrictions, such as if you are leaving Australia and taking a “reasonable quantity of the items for personal use”. You can see a full range of the exceptions on the Department of Home Affairs’ website.

How to get started

If you’re interested in starting a business importing medical devices such as face masks, we suggest you:

  • Get in touch with our expert freight forwarders here at International Cargo Express, providing us with the details of your supplier overseas, as well as the size and weight of the consignments; and

Final tip: Insure your Cargo

Finally, we recommend that, if you do decide to import face masks, hand sanitiser or other types of PPE, you insure all your cargo with a solid marine insurance policy. There is plenty that can go wrong, including loss or damage to your goods, theft, improper handling, fire, collision, natural disasters and even piracy.

At ICE, we are able to offer marine insurance for your goods so they are protected throughout the shipping process.

Questions?

If you’ve got any further questions about importing face masks and other protective equipment into Australia during the COVID-19 era, our expert freight specialists are here to help. Give us a ring for a free chat or you can leave a comment below.

Request a Free Quote or call us on 1300 227 461

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What Others Are Saying About International Cargo Express

Managed goods end to end

Due to critical stock levels we needed a fast solution to urgently meet growing client demand. Presented with this challenge, ICE quickly identified appropriate freighter services and proactively managed the movement of goods end to end.

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ICE offered flexibility

ICE offered flexibility, high levels of communication and attention to detail during our pick, pack and delivery project. With their professional support we were able to meet the demands of our supply chain knowing our freight was in safe hands.

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Since having International Cargo Express handle my ocean freight , I have had my bookings and equipment available without exception and on time. Communication between ICE and my supplier is very good and I receive information via my shipper before my supplier.

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[HOLIDAY REMINDER]From Thursday 1st October until Thursday 8th October the China Mid-Autumn Festival will take place.During this time many suppliers will be closed and we will have limited staff support overseas. Kindly place your orders well in advance of the festival and liaise with your suppliers regarding your shipments beforehand.Please also notify your ICE team member if you have a shipment you would like to leave from the 9th October onwards. It is important we have as much notification about orders straight after the festival to avoid disappointment.

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