Australia’s Therapeutic Goods Administration yesterday released a three-part action plan looking to strengthen the company’s medical device regulatory system.
The plan includes steps to improve oversight of new devices entering the market, strengthening post-market monitoring and providing more device information to patients.
The changes are slated to take effect in early-to-mid 2019 and continue into 2020, according to the official TGA posting.
The changes include open public consultations to seek feedback on the proposals, the TGA said, adding that decisions on specific policies and regulations would need to be made by the government.
The TGA said that currently, very low risk devices can be self certified, while all other devices must be assessed by a qualified body to show it meets the country’s “Essential Principles.” Some medium risk devices are also subject to further assessments, while high risk devices must either be examined by the TGA or subjected to a detailed audit by the TGA prior to it becoming available in Australia.
In its new proposal, the TGA said that it will look to reassess whether self-certification of low risk devices is appropriate as well as establishing a specialist unit to evaluate emerging tech including 3D-printed devices and software applications. The group will also look to provide clearer guidance on cybersecurity requirements for connected medical devices and IT systems, according to the release.
The TGA said that it will also seek to review whether more medium-risk devices should undergo mandatory audits before approval, as well as arrangements made for the use of medical devices in clinical trials. The action plan also includes improved communication of regulatory requirements for both Australians and the industry.
Oversight of high risk devices will also be assessed, through which the “TGA will consult on whether the Government should require greater levels and scrutiny of clinical evidence for certain groups of devices,” according to the release.
High-risk devices under consideration include spinal implants, devices that make diagnoses, diabetes management devices, in-vitro fertilization devices and companion diagnostics.
Turning to post-market monitoring, the TGA said that it will look to improve its adverse event reporting systems and develop “simpler ways for consumers to report adverse events (including using smartphone apps) and publicize how reporting of adverse events can improve the safety of products,” according o the posting.
The administration said that it will work healthcare facilities and health departments to explore new ways to increase information sharing about device safety and effectiveness, which may include developing education programs and systems to help identify and report medical device events in healthcare environments.
The TGA said it will also review “any regulatory or legal barriers that may currently compromise the ability of the TGA to respond quickly to device safety reports received from hospitals.”
The administration said that it will analyze the feasibility of a Unique Device Identifier system, as well as the possibility of increased inspections for medical device manufacturing sites.
In its public-facing strategy, the TGA said that it will partner with consumer groups to co-design a strategy to raise awareness about the regulatory system and about how regulatory decisions were reached for individual products, with a focus on higher-risk devices.
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