The Australian regulatory authority, the TGA, is taking steps to improve the existing regulation in the sphere of manufacturing and use of medical devices through what is known as the “Action Plan”. The main goal of the Action Plan, published on April 4, 2019, is to amend the marketing authorisation procedure, improve the monitoring of the use of the devices, and provide patients with detailed and accurate information on the medical devices they use. The document goes over existing regulations, the proposed amendments, and the timeframes for when the changes will be enforced.
The regulatory requirements currently existing in Australia are the most detailed and strict in the Asian-Pacific region. For example, the current legislation requires medical device manufacturers to register even low-risk devices, which is not common in other countries of the region like South Korea or Singapore. Australian medical device regulations even include the detailed rules to regulate medical software used in devices and even allow usual devices, like smartphones, to obtain and analyse any health-related information.
What would be changed?
The proposed Action Plan includes a wide list of changes to be made to the existing regulatory framework to improve the protection of the public. The most important changes would take place in the following spheres:
- Filling a marketing application: the existing assessment procedure for low-risk devices would be revised and improved. The changes will also include special rules for the manufacturers of innovative products to disclose full information about their medical devices to the public. Additional rules will also cover cybersecurity issues. The assessment requirements for medium and high risk devices will be discussed with the main stakeholders to take into account the position of each party.
- Monitoring of the use of the medical devices: the upcoming amendments would implement a new monitoring system. This system will allow for the detection of any problems with medical devices to occur earlier in order to prevent any harm to the public health. There will also be a change that requires the reporting of any accidents related to medical devices used throughout hospitals and other healthcare facilities. Some of the existing exemptions would be removed. The regulating authority aims to improve the safety of the products.
- The disclosure of the information about the medical devices: the lack of information related to the medical devices, especially about the most innovative ones, creates concerns for both the regulating authority and the public. Most of the information provided uses technical language that makes it difficult to understand it for non-specialists. That is why the new regulations will add an additional requirement to disclose information on the most important issues related to the use and the impact of medical devices. First of all, the aforementioned rules would be applied to the high risk devices. The idea here is to provide the public with customer-friendly information related to each medical device. At the same time, the regulating authority is going to establish special joint groups composed of both consumers and representatives of the industry.
The impact on the industry
The adoption of the Action Plan will speed up the process of the improvement of the existing regulatory framework, focusing on transparency and the efficiency of the medical regulatory system in general. At the same time, the implementation of the new requirements will require the manufacturers of medical devices to make detailed efforts to register their products. It is important to keep in mind that the Australian market authorisation could help manufacturers in entering new markets. Similar to several other countries, the medical devices regulated in Australia would be exempt from the registration.