Regulatory requirements for dental products
Information document no. 30
The Therapeutic Goods Act 1989 (the Act) provides the legislative basis for uniform national controls over therapeutic goods, including dental products such as amalgam, water based cements, powered dental equipment, implants, and materials of biological origin. Unless specifically excluded or exempt, therapeutic goods may not be supplied in Australia or exported unless the product is included in the Australian Register of Therapeutic Goods (ARTG) by an Australian 'sponsor'. It is an offence to use and/or import a product that is not on the ARTG.
The new medical device regulatory system
The new Australian regulatory system for medical devices came into force on 4 October 2002. The new system brings Australia into line with international best practice by harmonising with the principles for the regulation of medical devices developed by the Global Harmonisation Task Force (GHTF). The GHTF is an international group of medical device regulators and industry representatives from the USA, Canada, Europe, Japan and Australia who are working towards a global regulatory system for medical devices by developing broad principles for the regulation of medical devices that can be implemented by individual jurisdictions.
Australia's medical devices regulatory system is based on:
- a set of risk based classification rules by which medical devices are classified into one of five categories, Class I (low risk), Class IIa (low-medium risk), Class IIb (medium-high risk), Class III (high risk), and Active Implantable Medical Device (high risk);
- a set of essential principles for safety and performance that must be met by all medical devices;
- conformity assessment procedures used to demonstrate medical devices conform with the essential principles;
- a requirement for manufacturers of medical devices to have a quality management system in place for the manufacture of medical devices. This quality management system has to be assessed by an external regulatory agency for all devices, except the lowest risk category (Class I non-sterile and non-measuring);
- the presumption that a medical device conforms with the essential principles if compliance with nominated harmonised standards can be demonstrated;
- post-market monitoring by both the manufacturer/sponsor and the TGA; and
- retention of previous requirements for advertising.
The Therapeutic Goods Act 1989 has been amended to bring the new system into effect. The scope of medical devices regulated under the new system is much wider than under the previous system and very few products that fit the definition of a medical device will be exempt or excluded from the regulatory requirements. The new legislation provides for a two year transition period for devices that were previously exempt or excluded from the regulatory requirements.
Examples of dental products by class are:
- Class I - dental impression materials, artificial teeth, hand-held dental mirror, dental patient chair, dental curing light;
- Class IIa - dental filling materials and pins, dental alloys, ceramics and polymers, powered dental drill, X-ray film, orthodontic wire, fissure sealants, dental aspirator tips;
- Class IIb - diagnostic X-ray sources, non-absorbable sutures, permanent implants;
- Class III - absorbable sutures, absorbable implants.
NOTE: Assignment of Class is a responsibility of the manufacturer, and can vary for similar devices dependent upon the manufacturer's intended purpose.
Under the new system the level of regulatory control will be proportional to the degree of risk associated with the use of the medical device, taking into account the level of invasiveness in the human body, duration of use, location of use and whether the device is powered or not. This approach ensures appropriate management of any risks associated with new and emerging technologies.
Dental appliances made to specific design characteristics set out in a prescription for a specific person are considered to be custom-made devices. Removable dentures, fixed dental prostheses, bridges and crowns that are manufactured using standard off the shelf components and may include some custom made components are considered to be a customised device. For customised devices the standard, off the shelf, components are required to be included in the ARTG, however, any custom-made components and the assembled device are currently not required to be included in the ARTG. The professional activities of the dentist (eg. preparation, impression taking, prescribing, final fitting and any adaptation) are generally outside the scope of the new system.
Direct importation of products
Access to unapproved product
There are four mechanisms by which individuals can gain limited access to unapproved medical devices in Australia: use in clinical trials; via the Special Access Scheme (SAS); through an authorised prescriber and by personal importation. The operation of the four mechanisms remains the same under the new medical device regulatory system, with the exception of the SAS, where a new mechanism of notification of use of unapproved products in patients with life-threatening illness has been introduced. These changes align the operation
Use in clinical trials. The operation of the Australian Clinical Trial Notification (CTN) Scheme and the Clinical Trial Exemption (CTX) Scheme remains the same under the new regulatory system.
Under the CTN Scheme, the Human Ethics Research Committee (HREC) associated with the institution in which the trial is to be conducted gives ethical and scientific approval for the trial. Following approval by the HREC, the TGA is notified of the conduct of the trial. Under the CTX Scheme, the TGA reviews summary scientific information about the product and decides whether or not to object to the proposed use of the product. HREC approval of each CTX protocol and approval from the institution for the conduct of each trial are still required.
Special access scheme. The SAS refers to arrangements that provide for the import and/or supply of an unapproved medical device for a single patient, on a case by case basis. A medical practitioner can supply unapproved medical devices to seriously ill patients (category A) without TGA approval provided the TGA is notified within 28 days. Category A patients are defined in the legislation as "persons who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment". The medical practitioner is required to certify: that the patient falls within the Category A classification; the patient has given informed consent to the treatment; and that he/she will use the product in accordance with acceptable medical practice.
- the individual has a clinical need for the device;
- no other device currently on the market is suitable; and
- the device has acceptable performance and safety in relation to its proposed use.
Authorised prescribers. Certain medical practitioners are authorised by the TGA to prescribe a specified unapproved medical device or class of unapproved device to specified recipients or classes of recipients suffering from serious (but not necessarily life-threatening) medical conditions. In this situation, the medical practitioner, known as an 'Authorised Prescriber', can prescribe the specified medical device within the terms of the authorisation to patients in his/her immediate care, without the requirement for further approval from the TGA.
To become an authorised prescriber a medical practitioner requires an endorsement from the ethics committee of the hospital in which they are engaged in clinical practice, or from an appropriate ethics committee if they are treating patients outside a hospital setting. Where the medical practitioner can demonstrate he/she does not have access to an ethics committee, endorsement from an appropriate specialist college is acceptable.
Personal importation. Unapproved medical devices can be imported by individuals where the product is intended only for use by the importer or a member of the importer's immediate family. Individuals cannot import any product that contains material of human or animal origin, or a substance that is prohibited under Australian Customs legislation. An SAS approval is required for these products. There are further limits imposed on the quantities of product that can be imported by a single act of importation and over any 12 month period.
Further advice may be obtained from the Therapeutic Goods Administration, Office of Devices, Blood and Tissues, PO Box 100, Woden ACT 2606. Phone 02 6232 8438; Toll Free 1800 020 653 or visit the medical devices page on this website.