Guide to Australian Medical Device Standards and Regulations

Medicine involves the use of a vast array of innovative devices. While the use of such devices could involve a level of risk to patients, these risks can be mitigated through medical device regulation and standardisation.

Topics: Medical Device Standards

Medical Device screening

Regulatory systems help ensure not only safety for users, but also reliability, predictability and quality of products.

What is medical device regulation?

Medical device regulation is a regulatory framework for devices used in medicine and healthcare settings. This includes such products as monitors, syringes, X-Ray equipment, software, ventilators and implants.

In Australia, the regulation of medical devices is overseen by the Therapeutic Goods Administration (TGA). The regulatory system sets down the criteria for the safety, performance and quality of medical devices in Australia.

The framework also classifies devices according to risk. For example, a tongue depressor is classified as a Class I low risk device while a heart value is in the Class III high risk category.

Why is medical device regulation important?

Medical devices are used for a range of purposes. These include diagnosis, monitoring, treating diseases, easing symptoms, replacing body parts, supporting conception, examining specimens and many more.

It’s essential that the devices are as accurate as possible and do no harm. The regulatory framework helps fulfill this requirement by ensuring the products work as designed, and that they are safe to use for medical industry staff and patients.

Published Standards form a part of the system that helps to ensure medical devices meet the conformity assessments set down by the TGA, in turn making them safe and dependable to use.

Medical Device Standards list

Intertek Inform provides a range of published medical device standards through our online store.

AS 5369:2023 – specifies requirements and practices for reusable medical devices and other devices in terms of reprocessing, storage, handling and transport.
AS ISO 13485:2017 – covers the requirements for quality management systems regarding medical devices. This enables organisations to demonstrate their ability to provide services using devices that meet regulatory requirements and customer needs.
AS ISO 14971:2020 – this document specifies principles for a risk management process for manufacturers of medical devices, including software and in-vitro diagnostic products.
ISO 13485:2016 – covers the requirements for quality management systems in order to comply with regulations with regard to medical devices.

Medical device Standards encompass a broad range of topics, including protective gloves, digitised health records, sterilisation of products and protective clothing.

Standards and Regulations help to ensure the safety and reliability of devices used in medical settings for patient diagnosis and care. Discover our collection of 1.6 million Standards from more than 360 publishers.