Importing Hygiene Items and Protective Gear

If you are looking to import hygiene items or PPE during the COVID-19 crisis, ICE are here to help. Please see below details of tariff rates and documentation requirements.

If you are considering exporting these products, the Federal Government is moving to ban and heavily penalise Australians from exporting face masks and hand sanitiser to China, with those caught facing up to five years in prison. On this basis ICE will be able to support with imports only.

Face Masks – Import Customs Information

Tariff No: 6307.90

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

Labelling: Goods must be labelled with a description of the product and country of origin. The labelling cannot make any claims that are false or misleading

Registration Requirements: The presentation and claims made regarding face masks and gowns will determine how these products are regulated by the TGA under the Therapeutic Goods Act 1989 (the Act).

Face masks and gowns which 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 TGA under the Therapeutic Goods Act (The Act). You may wish to contact Australian Border Force and the Australian Competition and Consumer Commission (ACCC) regarding this.

Please see New Therapeutic Goods (Declared Goods) Order 2019 as this declares particular goods or classes of goods to be therapeutic goods, or not to be therapeutic goods, for the purposes of 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.

If these masks or gowns are supplied as non-sterile, they are likely to be regulated as low risk, class I medical devices.

Unless exempt, all products presented as therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) before being imported into, supplied in or exported from Australia.

Please see Overview of medical devices and IVD regulation for introductory information.

How to make an application

In order for a product to be included in the ARTG, a sponsor must submit an application to the TGA, together with relevant supporting data. The sponsor of a therapeutic good included in the ARTG must be an Australian resident and/or carrying on business in Australia.

Applications to include medical devices in the ARTG are completed online through TGA’s Business Services (TBS) portal. You will need to go TGA Business Services and complete the appropriate services forms in order to obtain a Client ID so that you can submit your medical device application.

The Australian Register of Therapeutic Goods (ARTG) inclusion process guidance includes information about:

• factors you will need to consider before you submit your application
• whether your product is a medical device
• whether your product is exempt or excluded from the requirement to be included in the ARTG
• information about the kinds of evidence and documentation you will need to submit a valid application and maintain your inclusion in the ARTG
• the cost of submitting your application and the annual fee associated with maintaining your inclusion in the ARTG
• information about the processing of your application, including the process of audit

Therapeutic Goods Administration contact details:
Phone: 1800 020 653
Fax: 02 6203 1605
Email:

Hand Sanitiser – Import Customs Information

Tariff No: 3402.90 or 3808.90 depending on preparation.

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

Labelling: Goods must be labelled with a description of the product, country of origin and have an ingredient listing. The labelling cannot make any claims that are false or misleading.

Registration requirements

Hand sanitisers are regulated under either general consumer products (cosmetics) by NICNAS or Therapeutic goods depending on the ingredients and the claims made about their effects.

NICNAS

Hand sanitisers as cosmetics

Hand sanitisers or antibacterial skin preparations with claims that are limited to low level activity against bacteria or germs (for example, kills 99.9% of germs) and with no claims against viruses, that are for use as a hand sanitiser for personal or domestic use only and not in a health care setting, and that do not contain a substance that is included in Schedules 2,3,4 or 8 of the Poisons Standard are excluded therapeutic goods and are therefore not regulated by the TGA. These products are regulated as General Consumer Products (cosmetics). The National Industrial Notification and Assessment Scheme (NICNAS) regulate the ingredients in cosmetics and the Australian Competition and Consumer Commission (ACCC) regulates the labelling. The Therapeutic Goods (Excluded Goods) Determination 2018 has a comprehensive list of when antibacterial skin preparations cross over the therapeutic boundary.

https://www.nicnas.gov.au/cosmetics-and-soaps/hand-sanitisers

NICNAS contact: 1800 638 528

Therapeutic Goods Administration

Antibacterial hand hygiene products such as hand sanitisers, hand washes and hand rubs that claim to kill specific organisms (eg E.coli or viruses) or any antibacterial skin preparations that are to be used in clinics or hospitals are regulated as registered non-prescription medicines, also called Over-The-Counter (OTC) medicines, and are individually evaluated by the TGA for quality, safety and effectiveness prior to inclusion on the ARTG.

Products for therapeutic use must be manufactured by TGA-licensed manufacturers in accordance with the principles of Good Manufacturing Practice (GMP), and must be included in the Australian Register of Therapeutic Goods (ARTG) before being imported into, supplied in, or exported from Australia. In order for a product to be included in the ARTG, a sponsor must submit an application to the TGA, together with relevant supporting data. The sponsor of a therapeutic good included in the ARTG must be an Australian resident and/or carrying on business in Australia.

https://www.tga.gov.au/hand-sanitisers-and-covid-19

Therapeutic Goods Administration contact details:
Phone: 1800 020 653
Fax: 02 6203 1605
Email:

Gloves, Goggles, Gowns and Personal Protective Equipment – Import Customs Information

Tariff No: Various

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

Registration Requirements

The presentation and claims made regarding face masks and gowns will determine how these products are regulated by the TGA under the Therapeutic Goods Act 1989 (the Act).

Face masks and gowns which 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 TGA under the Therapeutic Goods Act (The Act). You may wish to contact Australian Border Force and the Australian Competition and Consumer Commission (ACCC) regarding this.

Please see New Therapeutic Goods (Declared Goods) Order 2019 as this declares particular goods or classes of goods to be therapeutic goods, or not to be therapeutic goods, for the purposes of 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.

If these masks or gowns are supplied as non-sterile, they are likely to be regulated as low risk, class I medical devices.

Unless exempt, all products presented as therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) before being imported into, supplied in or exported from Australia.

Please see Overview of medical devices and IVD regulation for introductory information.

How to make an application

In order for a product to be included in the ARTG, a sponsor must submit an application to the TGA, together with relevant supporting data. The sponsor of a therapeutic good included in the ARTG must be an Australian resident and/or carrying on business in Australia.

Applications to include medical devices in the ARTG are completed online through TGA’s Business Services (TBS) portal. You will need to go TGA Business Services and complete the appropriate services forms in order to obtain a Client ID so that you can submit your medical device application.

The Australian Register of Therapeutic Goods (ARTG) inclusion process guidance includes information about:

• factors you will need to consider before you submit your application
• whether your product is a medical device
• whether your product is exempt or excluded from the requirement to be included in the ARTG
• information about the kinds of evidence and documentation you will need to submit a valid application and maintain your inclusion in the ARTG
• the cost of submitting your application and the annual fee associated with maintaining your inclusion in the ARTG
• information about the processing of your application, including the process of audit

Therapeutic Goods Administration contact details:
Phone: 1800 020 653
Fax: 02 6203 1605
Email:

Should you have any questions regarding the import of any of the items above, please contact our experienced staff for a free consultation.

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