What you need to know
- On 4 April 2019, the Therapeutic Goods Administration (TGA) released its "Action Plan for Medical Devices" (the Action Plan).
- The Action Plan identifies current issues with the regulation of medical devices. It proposes ways to improve the approval process for medical devices, the monitoring of medical devices already in use, and the information available to patients about products.
What you need to do
- Manufacturers, suppliers and users of medical devices, as well as healthcare facilities and other stakeholders, are encouraged to monitor and participate in public consultations arising out of the Action Plan over the coming year.
Medical devices play a vital role in the treatment of patients. They include a wide range of products manufactured both locally and offshore, from bandages and syringes to spinal implants and pacemakers. Technology has had an enormous impact on medical devices and has resulted in a greater level of sophistication and effectiveness of products on the market. It is crucial that approved medical devices are safe and fit for purpose to both patients and the end user.
The TGA, which is part of the Department of Health, regulates medical devices in Australia. It does so primarily by assessing medical devices based on their level of risk.
On 4 April 2019, the TGA released an Action Plan to improve Australia's medical device regulatory framework. The TGA found that, whilst the regulatory requirements in Australia are some of the most stringent in the world, more can be done to strengthen the system to place patient safety first.
Action Plan
The Action Plan is a three part strategy to:
- improve how new devices get on the market in Australia;
- strengthen the monitoring and follow up of devices already in use; and
- provide more information to patients about the devices they use.
The TGA will be seeking feedback on the proposed policies, regulations and guidance materials developed in relation to the Action Plan during the coming year. The Action Plan may lead to changes to the laws and regulations affecting medical devices in 2020 and beyond.
Strategy 1: Improve how new devices get on the market
Every medical device is required to meet a set of requirements known as the 'Essential Principles' before they can be supplied in Australia. The Essential Principles require manufacturers to provide evidence on matters such as: safety requirements; protection from infection and microbial contamination; and the information that must be supplied with the medical device.
The assessment of a product is carried out by the TGA or its international equivalent and will depend on whether the product has a low, medium or high risk. Manufacturers for low risk devices can self-certify that their devices meet the Essential Principles, whereas medium to high risk devices undergo third party assessments and can be subject to detailed auditing before approval is granted.
The TGA proposes to strengthen its assessment processes and oversight of how devices are approved for use in Australia. This is particularly important in light of emerging technologies such as 3D printed devices and medical software, to ensure they are safe to use and reliable. A specialist unit will be established to aid in the task of evaluating the efficacy and safety of contemporary medical devices, including cybersecurity risks. The TGA will also consider whether mandatory audits should be required for medium to high risk devices, and review arrangements for devices used in clinical trials.
Strategy 2: Strengthen monitoring and follow-up of devices already in use
The TGA currently monitors the safety and performance of medical devices after they have been approved and made available to Australian patients. This is achieved through mandatory reporting of adverse events by industry, and voluntary reporting by the public, healthcare professionals and other regulators.
The TGA proposes to introduce systems to improve its ability to identify problem medical devices earlier, by considering:
- mandatory reporting requirements for healthcare facilities when a problem with a medical device is identified; and
- whether the TGA should have enhanced powers for recalls and in relation to cancelled devices.
Further, the TGA intends improve communication between itself and overseas regulators who have had reports of adverse events in relation to medical devices that are also used in Australia.
Strategy 3: Provide more information to patients about the devices they use
The TGA considers that there is a very low level of consumer awareness about the TGA and its regulation of medical devices, and that the information currently available about medical devices is difficult to navigate and not easily understood.
The TGA intends to overcome this by partnering with consumer groups to design a strategy to raise awareness about the regulation of medical devices, including how medical devices are approved.
What next?
The TGA will be consulting with the public in relation to the three strategies during 2019.
Manufacturers, suppliers and users of medical devices, as well as healthcare facilities and other stakeholders, are encouraged to monitor and participate in public consultations arising out of the Action Plan over the coming year.
For further information, please visit the TGA's website by clicking here.
Authors: Dario Aloe, Lawyer and Stuart D'Aloisio, Partner.
