Revised regulatory reporting requirements for dental laboratories

As a result of the Australian Dental Industry Association's (ADIA) engagement with the Therapeutic Goods Administration (TGA), there have been revisions to the regulatory standards for dental laboratory products.

Local dental laboratories and professionals importing and supplying dental laboratory products now have two months to formally notify the TGA of their obligations.

Dental laboratory products such as crowns, bridges and dentures are, for regulatory purposes, referred to as "custom-made medical devices". The Australian Government agency with regulatory oversight of custom-made medical devices is the Therapeutic Goods Administration (TGA).

Custom-made medical devices are defined in the Therapeutic Goods (Medical Devices) Regulations (Cth) 2002, hereafter simply referred to as "the Regulations", as medical devices that are made specifically in accordance with a request by a health professional (e.g. a dentist or dental prosthetist) specifying its design characteristics or construction. They are intended to be used only in relation to a particular individual, or by a health professional to meet special needs arising in the course of his or her practice.

Required design and performance standards

With respect to custom-made dental appliances, products manufactured by labs both in Australia and overseas are required to meet conformity assessment procedures regulated by the TGA. These require compliance with the relevant Essential Principles set out in the Regulations. There are six general Essential Principles that apply to all medical devices which are as follows:

• Use of a medical device not to compromise health and safety;
• Design and construction of medical devices to conform with safety principles;
• Medical devices to be suitable for intended purpose;
• Long-term safety;
• Medical devices not to be adversely affected by transport or storage; and
• Benefits of medical devices to outweigh any undesirable effects.

There are a further nine Essential Principles about design and construction that apply to medical devices on a case-by-case basis. These provide minimum chemical, physical and biological properties in addition to a range of matters not related to custom-made medical devices such as requirements for medical devices connected to or equipped with an energy source.

The Therapeutic Goods Act (Cth) 1989, hereafter simply referred to as "the Act", defines who is responsible for compliance with the regulatory standards for custom-made medical devices - they are known as the "Sponsor".

A Sponsor is the person or organisation that imports or supplies medical devices in Australia, or exports medical devices from Australia.

The sponsor can be the manufacturer (e.g. a dental laboratory), a dentist, dental prosthestist or someone else. For example, where an Australian dental laboratory supplies their product directly to dental professionals, they will be both a manufacturer and a "Sponsor" under the Regulations. For clarity, in this article, it is assumed the dental laboratory is the manufacturer.

Dentists and allied oral healthcare professionals can import custom-made medical devices from overseas, but in doing so they become the Sponsor and are subject to the Sponsor's obligations as set out in the legislation.

Revised reporting obligations

In early 2016 the TGA worked with the ADIA to improve how dental laboratories and Sponsors/Importers of custom-made medical devices can meet their reporting obligations.

A dental lab making a custom-made medical device in Australia must give the following information to the TGA:

• The manufacturer's name and business address; and
• A description of the kinds of medical devices being custom-made by the manufacturer.

The Sponsor of a custom-made medical device that is imported into Australia must give the following information about the device to the TGA:

• The sponsor's name and address;
• The manufacturer's name and business address;
• A description of the kinds of medical devices being custom-made by the manufacturer (including the device nomenclature system code for any such devices).

This reporting requirement has always existed; the change introduced in early 2016 required that the dental laboratory or Sponsor/Importer, as is appropriate, has two months to provide the TGA with this information.

A simple notification form makes it quick and easy to notify the TGA about your custom-made medical device. This easy-to-use online form can be accessed at www.tga.gov.au/custom-made-medical-devices

Once the form has been completed, you will receive an automated confirmation that you have submitted the information. Only basic information is required to complete the form (as set out above) and it should only take five minutes or so to complete.

The manufacturer or Sponsor/Importer will only have to notify the TGA on one (the first) occasion if they are supplying the same kind of medical-device. A medical device is taken to be of the same kind as another medical device if they meet all four of the following requirements:

• Have the same sponsor; and
• Have the same manufacturer; and
• Have the same GMDN code; and
• Have the same medical device classification.

For example, if you are the Sponsor of dental laboratory products that are all captured under the same GMDN code (e.g. 38595: Dental crown, polymer - a device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific patient, that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth) and all made by the same manufacturer and all of the same device classification you will only need to notify the TGA once.

Custom-made medical devices are exempt from inclusion on the Australian Register of Therapeutic Goods (ARTG). This means they do not need to be included on the ARTG to be legally supplied in Australia; however, both the dental laboratory and Sponsor/Importer of a custom-made medical device still have obligations to ensure the relevant essential principles have been met (to demonstrate the quality, safety and performance of the medical device) and a conformity assessment procedure has been applied (to generate evidence that the custom-made medical device complies with the essential principles).

It is important to note that the manufacturer and Sponsor/Importer are also required to report adverse events and comply with any advertising requirements.

The information dental laboratories should keep

As the manufacturer, the dental laboratory, whether they be based in Australia or overseas, must prepare (and keep up-to-date) a written statement in relation to the custom-made medical device when it is supplied in Australia. This includes:

• The name and business address of the manufacturer;
• Sufficient information to enable the user to identify the device or, if relevant, the contents of packaging;
• A statement to the effect that the device is intended by the manufacturer to be used only in relation to a particular individual or health professional;
• The name of the individual in relation to whom the device is intended to be used;
• The name and business address of the health professional who provided the specification for the device;
• The particular design characteristics or construction of the device as specified by the health professional who provided the specification for the device;
• A statement to the effect that the device complies with the applicable provisions of the essential principles or, if the device does not comply with all applicable provisions of the essential principles, a statement explaining which provisions of the essential principles the device does not comply with and the reasons for the non-compliance; and
• Information in relation to the design, production and intended purpose of the device.

As with any regulatory requirements, the arrangements associated with custom-made medical devices are subject to change - thus you are encouraged to seek independent expert advice concerning your responsibilities.

More info on the work that ADIA is undertaking to support the dental laboratory sector can be found online at the Australian Dental Industry Association website.