As a regulator, the TGA ensures that the Australian community has access, within a reasonable time, to therapeutic advances. The regulatory framework is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden.
Overview Of The Regulatory Environment
The Australian Dental Industry Association (ADIA) encourages an open market which supplies dentists and oral healthcare professionals with a range of products at a competitive price. Underpinning this is the need for confidence that the products supplied by the dental industry are safe and comply with the standards and regulations designed to achieve this outcome.
The Australian community expects that medicines and medical devices in the marketplace are safe and of high quality, and of a standard at least equal to that of comparable countries. The objective of the Therapeutic Goods Act (Cth) 1989 is to provide a national framework for the regulation of therapeutic goods in Australia to ensure the quality, safety and efficacy of medicines and ensure the quality, safety and performance of medical devices. For the purposes of the legislation most types of dental equipment and many of the consumables used in dental practices are deemed to be medical devices.
Importing Products - Key regulatory requirements
Under Australian law most therapeutic devices need to be supplied in accordance with the framework established by the Therapeutic Goods Act (Cth) 1989. This legislation is administered by the TGA which regulates the quality, safety and performance of medical devices (e.g. dental equipment) that are manufactured, imported and / or supplied in Australia.
The TGA has established a classification system for medical devices based upon the risk to the patient, user and environment. The classification allows the TGA to set more complex standards and monitoring regimes for higher-risk medical devices.
All types of medical devices (including dental equipment) must appear on the Australian Register of Therapeutic Goods (ARTG). It is the responsibility of each Australian manufacturer or importer to organise the ARTG entry, even if an identical product (i.e. the same product) is being imported by another party and already on the ARTG.
Some types of equipment, such as x-ray imaging devices, may also need to be installed and operated in accordance with state legislation.
Importing Products – Key standards requirements
Most types of equipment need to be manufactured in accordance with the relevant product technical standard which many include an International Standard (ISO), Australian Standard (AS), joint Australian / New Zealand Standard (AS/NZS), European Standard (CEN) or an American Standard (ANSI).
Manufacturers of medical devices must ensure that their devices comply with all applicable rules and regulations
that relate to the operation or supply of their device in Australia, regardless of whether the requirements directly relate to medical regulatory aspects or not. For example, a manufacturer of an electrically powered medical device that uses water must comply with each of the appropriate electrical and water regulatory requirements that apply nationally and in each of the states and territories.
Depending on the piece of equipment these technical standards may govern the design, manufacture, installation, calibration and maintenance of equipment. In many cases these standards will be referenced in regulations thus compliance with the standards is mandated by law. There are more than five hundred standards relevant to dental equipment and consumables in Australia and it is not therefore practical for ADIA to provide advice as to which standards are relevant to each type of product. Importers should also familiarise themselves for Quality System standards
It is necessary for an importer to have on record, or access to, documentation providing an independent assessment that a product meets the required standard(s).
The Australian Register of Therapeutic Goods
The ARTG is a computer database of therapeutic goods and in all but a very few cases medical devices must be included before they may be supplied in or exported from Australia. The ARTG is a computer database of information about therapeutic goods for human use approved for supply in, or exported from, Australia. There are around sixty thousand products listed on the ARTG.
The Therapeutic Goods Act (Cth) 1989 and subordinate legislation sets out the requirements for inclusion of therapeutic goods in the ARTG, including advertising, labeling, product appearance and appeal guidelines. Some provisions such as the scheduling of substances and the safe storage of therapeutic goods are covered by the relevant State or Territory legislation.
For a medical device to be included in the ARTG, the TGA must be satisfied that evidence exists appropriate to the perceived risks of the device to support its safe and effective use, and that an appropriate system is in place for monitoring the ongoing performance and safety of the device.
If an importer wants to supply a device that is identical to a device that is already in the ARTG, even if both devices are made by the same manufacturer, an application to include the device in the ARTG must still be made to the TGA. This is because the ARTG is not only a record of the devices that can be supplied in Australia, it is also a record of all the sponsors who are legally responsible for the medical devices on the market.
The Essential Principles
For a medical device to be supplied in Australia, it must be demonstrated that the relevant Essential Principles have been met. The regulatory framework provides flexibility for manufacturers and caters for technological advances and changes in the development of new medical devices by not dictating how a manufacturer must prove that they have met the Essential Principles.
The most common way to demonstrate compliance with the Essential Principles is to meet a standard published by an Australian or International Standards agency, or a similar standard. If the manufacturer chooses to use other voluntary standards they must provide evidence that the chosen standard is applicable to the manufacturer’s quality system and that its application satisfies the requirements of the and Therapeutic Goods Act (Cth) 1989 and subordinate Regulations.
There are six general Essential Principles that apply to all devices. There are a further eight Essential Principles about design and construction that apply to devices on a case by case basis.
General principles for medical devices are:
Medical devices not to compromise health and safety;
Design and construction of medical devices to conform to safety principles;
Medical devices to be suitable for intended purpose;
Medical devices not to be adversely affected by transport or storage; and
Benefits of medical devices to outweigh any side effects.
The principles about design and contstruction include:
Chemical, physical and biological properties;
Infection and microbial contamination;
Construction and environmental properties;
Medical devices with a measuring function;
Protection against radiation;
Medical devices connected to or equipped with an energy source;
Information to be provided with medical devices; and
Once a design specification that minimises the identified risks has been defined, the manufacturer will need to decide how to demonstrate that it meets the relevant Essential Principles. In many instances this will be achieved through implementation, maintenance and regular inspection of a quality management system by the device manufacturer.
An importer must ensure that the medical devices that they import comply with the Essential Principles and that they have available sufficient information to substantiate that compliance with the Essential Principles or have procedures in place, including a written agreement, to ensure that such information can be obtained from the manufacturer within twenty working days. The TGA may request this information at any time without the need to show cause as to why they require the information.
Regulatory Compliance – Responsible persons
The legal framework established by the Therapeutic Goods Act (Cth) 1989 requires that each manufacturer and importer be responsible for ensuring that the piece of dental equipment complies with the requirements of the legislation and is supplied in the same fashion. The legislation refers to the manufacturer and suppliers as the "Sponsor" of product as they sponsor the supply of product to the Australian market place and are also responsible for ensuring that the product appears on the ARTG.
Under the Therapeutic Goods Act (Cth) 1989 the Sponsors of medical devices supplied in and exported from Australia are required to keep distribution records of the medical devices. This is required to expedite any recalls of batches of the medical devices and identify the manufacturer of each batch of devices.
Importers are not required to maintain records of the individual users of medical devices, however the importer should have records of distribution centres, hospitals and export countries the device has been supplied to. Each importer is required to retain the distribution records for their medical devices for between five and ten years (depending upon the class of medical device) after the last product has been distributed.
Importer’s Ongoing Responsibilities
An importer of medical devices that has successfully had a medical device listed on the ARTG has ongoing responsibilities. They are required to ensure that an appropriate conformity assessment procedure has been applied to the device. An importer is also required to ensure that they have available sufficient information to substantiate the application of those conformity assessment procedures or have procedures in place to ensure that such information can be obtained from the manufacturer within twenty working days
There are also guidelines governing the advertising and promotion of therapeutic goods and it is the importer’s responsibility to ensure that any advertising material relating to the medical device complies with the TGA requirements.
Important Note About Medicines, Biological Products & Locally Manufactured Products
Please note that the TGA has put it place different arrangements for medicines, biological products (blood products and products for human and / or animal origin) and therapeutic devices that are manufactured locally. For further information on these please contact the TGA or an appropriately qualified consultant.
The legislative framework governing the manufacture and supply of therapeutic devices is subject to constant review and it is a responsibility of each manufacturer and importer to monitory what changes are proposed, those that have been implemented and then determine how they apply to your company’s operations and the way that you distribute or manufacture goods. An excellent way to monitor changes to the regulatory, commercial and technical environment is to join the Australian Dental Industry Association (ADIA). Via fortnightly news updates and monthly newsletters ADIA keeps its members informed.
This information is provided for information purposes only and should not be relied upon when determining your company’s statutory obligations. ADIA recommends that you seek independent expert advice concerning your obligations with respect to the Therapeutic Goods Act (Cth) 1989 and related legislation.