To better align the in-country medical device framework with international best practice, the Australian Regulatory Guidelines for Medical Devices (ARGMD) is currently undergoing a major review and update. The Australian Regulatory Authority, the Therapeutic Goods Administration (TGA) has published their action plan for the overhaul of the medical device regulatory system back in April, 2019.
Their three-part action plan consists in:
- improving how new devices gain access to the market;
- strengthening the monitoring and follow-up of devices already in use;
- providing more information to patients about the devices they use.
Among the most important changes to the medical device regulations that the TGA intends to bring, we mention:
- improve the marketing authorization process for new devices and the follow-up of existing devices. While international requirements for medical device safety and performance have changes significantly, the Australian Essential Principles have remained the same since 2002. The draft of the proposed changes was published for consultation in September;
- conduct open public consultations to obtain feedback on proposed policies, regulations and guidance materials. TGA dedicated a section of their website to inform and educate the consumer;
- expand the regulations to cover new technologies such as 3D printed devices, software apps, and software as medical device (SaMD). Although software is regulated by the TGA under the existing medical device framework, advances in technology are not adequately covered in the current scheme;
- update the assessment process to address medical device cybersecurity risks and offer guidance on requirements for IT systems they connect with;
- clarify the regulatory requirements for medical device systems and procedure packs (SOPP);
- improve tracking and traceability of Medical Devices throughout the healthcare supply chain up to the patient using a Unique Device Identifier system.
As 2019 rapidly approaches its end, the proposed changes are undergoing consultation with consumer groups and healthcare industry representatives. It is the TGA’s intent to introduce the new legislation and to implement the agreed regulatory changes by early 2020.