ADIA is the peak business organisation representing manufacturers and suppliers of dental products. Our vision is for an industry that empowers oral health professionals to advance the health and wellbeing of all Australians...................... — ADIA Strategic Plan

For Professionals — Importing Products Yourself

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Thanks to the internet, it is easier than ever before for dentists and allied oral healthcare professionals to import dental products from overseas. Just as with clothing and consumer electronics, purchasing dental products online is often cheaper than purchasing products from distributors in Australia. The major difference is that in most cases if a dentist or allied oral healthcare professional purchases dental products, these products can’t be used on patients. To do so risks being prosecuted by the Australian Government and in many cases insurers will not cover use when using products from overseas – you may even have your professional registration suspended or cancelled.

The following questions are common amongst dentists and allied oral healthcare professionals seeking to import dental product.

What types of dental products are regulated?

Many products used in modern dentistry are classified as therapeutic devices under the Therapeutic Goods Act 1989 (Cth) and subordinate regulations administered by the Therapeutic Goods Administration (TGA). The legislation refers to those products that are used for humans; have therapeutic benefits; generally have a physical or mechanical effect on the body; or are used to measure or monitor functions of the body

The type of product falling within the scope of the regulations includes not only many common products used in dentistry such as braces, fillings, and dental tools such as syringes, but also a range of equipment including dental chairs, sterilisers, and x-ray machines through to instruments such as dental hand-pieces and forceps. The regulations also cover a wide range of mainstream healthcare equipment and products including artificial hips, blood pressure monitors, breast implants, catheters, lubricating eye drops, and tongue depressors.

Can dental professionals import medical devices for use in their clinical practice?

Yes, but to do so results in health professionals being subject to the requirements of the Therapeutic Goods Act 1989 (Cth) and subordinate regulations. Health professionals who import medical devices for use in their clinical practice are considered to be supplying the devices to the general public. Examples of importing dental products which fall within the legal definition of "supplying" the products includes purchasing from overseas through the internet or from mail order catalogues, or obtaining from international conferences and trade exhibits.

What if health professionals import medical devices under the personal importation provisions?

Health professionals can import medical devices under the personal importation provisions but NOT for use in their clinical practice (i.e. not for use on patients). The personal importation scheme can only be used to import a medical device for personal use or for the treatment of immediate family. Under the personal importation scheme, any individual may import a three month supply of unapproved therapeutic goods into Australia in any one importation without any approval required by the TGA provided that:

The devices are for the individual's own treatment or the treatment of immediate family;
The individual does not supply (sell or give) the devices to any other person; and
The other conditions of personal importation are met as part of the personal importation scheme.

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In a practical sense, although it is not illegal to purchase via the internet and use it on yourself or your immediate family, the imported product can not be used on or in connection with patient care.

A common misunderstanding amongst dentists and allied oral healthcare professionals is that the TGA approves dental products. This isn't the case which has implications when considering importing products - just because a product is already available in Australia doesn't mean that you can import the same product (even from the same manufacturer) and use it on patients. If you import the product, you are responsible for having it listed within the Australian Register of Therapeutic Goods (ARTG).

When importing a device already included on the ARTG, does another application need to be made to the TGA?

Each ARTG entry is unique to the sponsor, manufacturer, and the kind of dental product. Therefore, every sponsor (i.e. dentist importing product) needs to apply to the TGA to have their imported medical devices included on the ARTG, even if another sponsor already has an ARTG entry for the same device. In a practical sense, just because the medical device that you wish to purchase is already listed on the ARTG by someone else, it does not mean that you may lawfully supply the medical device yourself. If you intend to supply a medical device in Australia you must maintain your own ARTG entry for it yourself.

The regulatory standards for the supply of medical devices in Australia are complex and need to be met by all businesses supplying product in Australia. That is part of the reason that products available through suppliers in Australia are more expensive than those bought via the internet - there is a considerable burden associated with regulatory compliance costs.

What are the responsibilities of health professionals who supply medical devices?

If a dental professional supplies a dental product to the Australian market, including by using it in their clinical practice, they become the what the TGA calls a "sponsor" of the device. Simply, the dental professional has 'sponsored' the supply of that product in Australia and is legally responsible for it. Before dental products can be supplied to the Australian market, including by a dental professional using it in their clinical practice, health professionals must comply with all regulatory requirements as sponsors. Medical device sponsors are responsible for:

Applying to the TGA to have each kind of medical device included on the ARTG;
Ensuring the device continues to meet all legislative requirements once on the market;
Record keeping about medical devices supplied;
Reporting any adverse events or problems; and
Taking corrective or preventative action, such as recalls, if necessary.

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It is important that the regulatory standards for the supply of dental product be complied with. Not only does the TGA investigate allegations of illegal importation and supply, the supply of dental products is also monitored by other Australian Government agencies that includes the Australian Competition and Consumer Commission (ACCC) in addition the Australian Customs Services (ACS) and the Australian Quarantine and Inspection Services (AQIS). These agencies often have further regulatory requirements that need to be adhered

Are health professionals obliged to service the devices they have supplied?

When dental professionals become the sponsor of imported dental products, it is part of their obligations to fulfil the manufacturer's warranty and provide maintenance and servicing where required. It is important that health professionals who are sponsors understand that a condition of inclusion on the ARTG is that medical devices continue to meet all the relevant Essential Principles for safety and performance which has considerable implications with regards to maintenance and servicing of dental products. A healthcare professional is only responsible for the medical devices they have sponsored. If the same medical device has been supplied by another sponsor, then it is the other sponsor who is responsible for maintenance and servicing.

Although it may be tempting to purchase dental product via the internet and use it within your practice on patients, there are considerable risks in doing so and it is really not recommended.

What are the penalties associated with importing and supplying medical devices that do not meet regulatory requirements?

Dentists and allied oral healthcare professionals who do not comply with the import and supply regulations for dental products could face civil or criminal penalties of up to five years imprisonment and/or $550,000 in fines. Offences include:

Supplying dental products not included on the ARTG which includes using these products on patients;
Importing and/or supplying dental products that do not meet the essential principles;
Failing to apply conformity assessment procedures (for more information see the Australian regulatory guidelines for dental products);
Misrepresenting medical devices; and
Failing to report adverse events

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In addition, many insurance policies contain specific exclusions which allow the insurer to deny covering you in the event of a claim associated with a dental product that does not appear on the ARTG which would include any product that you have purchased online via the internet from an overseas source.

If this sounds complex and somewhat daunting, it is, but don't panic you are not alone! Indeed, there are nearly one thousand pages within the Therapeutic Goods Act 1989 (Cth) and subordinate regulations so if you want to purchase product via the internet and use it on patients, you better get reading. For further guidance, review the following documents:

Dental Product Internet Purchases Guidance —

TGA - Importing Medical Devices: Information for healthcare professionals
TGA - A summary of supplying imported therapeutic products in Australia
WHO - Medical devices and the internet


However, there is an easy alternative ... once you have found the product that you are after simply contact a business that is a member of the Australian Dental Industry Association (ADIA) who will assist you in purchasing products that are readily available within Australia. Australia’s dental industry plays an important role supporting dentists and allied oral healthcare professionals provide quality product and consumables to Australians. This relationship between industry and the professionals that deliver dental services is important in building public confidence in the safety, performance, benefits, and risks associated with the use of medical devices used in dentistry in the Australian market. ADIA’s role in this area is to keep industry (i.e. your suppliers) up to date with changes to regulations so as to ensure that dental equipment, consumables and services complies with TGA regulations.

Further Information —

If you have an interest in how ADIA seeks to build stronger links between the dental industry, dentists and allied oral healthcare professionals be sure to subscribe to the Twitter feed @AusDental or follow us on Facebook at www.facebook.com/dental.industry. Alternatively, you can contact ADIA national office team responsible for engagement with dental professionals via email at professional.relations@adia.org.au or by telephone on 1300 943 094.

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This information is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated.

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