Medical Device Regulation

Australia's device regulatory system is administered by the Therapeutic Goods Administration (TGA) and uses a risk-based classification system. This means that an implantable device such as a defibrillator carries a higher risk to the user than an item such as disposable face masks or theatre gowns.

It operates using a regulatory approach developed and recommended by Australia, the EU, USA, Canada and Japan. TGA assesses a prescribed list of manufacturers, including all those based in Australia, and for others, uses trusted third parties based overseas. All medical products used in Australia must meet the TGA requirements.

Working within a harmonised system is very important for Australia as it is a very small market. Patients in Australia would not have access to new technologies in many cases if the regulatory system here created greater barriers when compared with systems in other countries.

The classification of medical devices is based on:

  • the manufacturer's intended use of the device
  • the level of risk to patients, users and other persons (the probability of occurrence of harm and severity of that harm)
  • the degree of invasiveness in the human body.

Every manufacturer has to ensure that their products comply with a set of Essential Principles of safety and performance, including clinical performance, as well as documenting a comprehensive risk assessment for every product. For products above Class I, the manufacturer needs to have an independent certification of compliance.

The Class I classification applies to many devices which have been deemed as low risk and include such things as hospital beds, wheelchairs, stethoscopes and crepe bandages. They can be registered in Australia using an online application. TGA undertakes random audits to ensure compliance, including that the applicant has correctly classified the product.

Class IIA and Class IIB devices include monitoring equipment, theatre instruments, stents and catheters. The application to the TGA must be supported by evidence of conformity assessment (such as a CE certification) which indicates that the device has been fully examined under another regulatory system that is accepted by the TGA.

Class III and Active Implantable Medical Devices (AIMD) devices require not only evidence of conformity assessment but also a detailed and certified assessment of a design dossier. Class III devices include heart valves; AIMD classification include cardiac defibrillators and pacemakers.

TGA itself undertakes full conformity assessment on Class III devices which contain a medicine, human blood or plasma, or material of animal, microbial or recombinant origin. TGA assesses the manufacturer's quality management system which may include an onsite audit in addition to reviewing the technical documentation.

Medical technology companies invest significant amounts in research and development to continually improve the benefits of products to deliver good health outcomes to patients.

More information is available from theĀ TGA website.