Regulation
Does the TGA regulate medical devices?
The Therapeutic Goods Administration (TGA) regulates all medical devices that are imported into, supplied in or exported from Australia under the Therapeutic Goods Act 1989 (the Act).
Unless a specific exemption applies, medical devices must be included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia.
Importing medical devices
Can health professionals import medical devices for use in their clinical practice?
Yes, but to do so results in health professionals being subject to therapeutic goods 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 medical devices include purchasing from overseas through the internet or from mail order catalogues, or obtaining from international conferences and trade exhibits.
Does use in clinical practice really mean supply of a medical device?
Yes, the term 'supply' is defined in section 3 of the Act and does include supply to mean by way of administration to, or application in the treatment of, a person. Other definitions about supply of therapeutic goods in section 3 include:
- supply by way of sale, exchange, gift, lease, loan, hire or hire-purchase
- supply, whether free of charge or otherwise, by way of sample or advertisement
- supply, whether free of charge or otherwise, in the course of testing the safety or efficacy of therapeutic goods in person.
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. 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
- the other conditions of personal importation are met as part of the personal importation scheme.
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 device. Therefore, every sponsor 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.
Health professionals as sponsors
What are the responsibilities of health professionals who supplies medical devices?
If a health professional supplies a medical device to the Australian market, including by using it in their clinical practice, they become the sponsor of the device.
Before medical devices can be supplied to the Australian market, including by a health 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
- taking corrective or preventative action, such as recalls, if necessary.
For complete details of sponsor obligations, refer to the Therapeutic Goods Act 1989.
Are health professionals obliged to service the devices they have supplied?
When health professionals become the sponsor of a medical device, 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.
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.
Trade exhibitions
Can healthcare professionals purchase medical devices at Australian trade exhibitions?
Healthcare professionals can purchase medical devices from Australian trade exhibitions for use in their practices, as long as the devices are included on the ARTG.
Exhibitors are able to display new technologies that are not included on the ARTG at trade exhibitions to survey the market and determine the viability of importing the goods. There is an exemption under Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2002 that enables samples of a medical device to be examined, demonstrated and displayed. However, exhibitors must display a notice clarifying that such devices are not available for supply until they are included on the ARTG.
Penalties
What are the penalties associated with importing and supplying medical devices that do not meet regulatory requirements?
Sponsors and health professionals who do not comply with the import and supply regulations for medical devices could face civil or criminal penalties of up to five years imprisonment and/or 5000 penalty units (one penalty unit is currently valued at $330 under the Crimes Act 1914).
Offences include:
- supplying therapeutic goods not included on the ARTG
- importing and/or supplying medical devices that do not meet the essential principles
- failing to apply conformity assessment procedures (for more information see the Australian regulatory guidelines for medical devices)
- misrepresenting medical devices
- failing to report adverse events.
Suspect devices
What do I do if I have concerns about a medical device?
Health professionals who have concerns about the safety, efficacy or performance of a medical device, or suspect that a device does not meet legislative requirements, should submit a report to the TGA for investigation. The act of reporting an event is not an admission of liability for the event or its consequences.
This can be done via the TGA Internet site.