The Therapeutic Goods Administration (TGA) has announced a three part strategy to:
- strengthen oversight and assessment procedures to regulate the device to market pathway;
- strengthen safety monitoring and follow-up of devices in market; and
- improve transparency and provision of information to patients regarding medical devices.
It is anticipated that the Australian Federal Government will introduce legislation implementing associated regulatory changes by early 2020 after engaging in public consultation with key stakeholders on these strategies later in 2019. More information on the TGA Action Plan can be found here.
The Action Plan indicates that the TGA is moving to tighten regulation of medical devices at the pre-market and post-market stages of the product life cycle. The TGA's plan to increase the level of scrutiny of medical devices during the application process may result in more stringent clinical evidence requirements, a higher incidence of mandatory audits and longer lead times for approval of medium to high risk medical devices.
Sponsors of medical devices already in market will be focussed upon the impact of the TGA's proposed onsite audit of adverse event reporting procedures and potential changes to the adverse event reporting exemptions. Sponsors will have an opportunity to engage in the consultation process, either directly or via MTAA.
A high level summary of the TGA strategies which have the potential to impact medical device sponsors is set out below.
Strategy 1: Improving how devices get on the market
The TGA is reviewing whether the current process for self-certification of low risk devices is appropriate and considering whether to extend the mandatory pre-market application audit requirements to medium risk devices.
The TGA has indicated that consultation regarding these proposed changes will include: whether the government should require greater levels and scrutiny of clinical evidence for certain groups of devices (eg. spinal implants, devices that make diagnoses, diabetes management devices, medical devices used for IVF, and companion diagnostics).
In light of the increasing prevalence of medical software (SaMDs) and 3D printed devices, the TGA is also looking to establish a specialist unit to evaluate such new technologies to ensure they do not pose a significant risk to patient safety. The TGA anticipates this specialist unit will be equipped to assess and monitor digital health, including emerging issues such as cybersecurity risks, by mid-2019.
Strategy 2: Strengthen the Monitoring and Follow-Up of devices in market
The TGA will introduce systems to better identify issues with medical devices - for example, allowing consumers to report adverse events via a smartphone app. The TGA will also consult on:
- whether it ought to mandate healthcare facilities to report adverse events;
- whether to remove some existing reporting exemptions to require more timely and improved reporting of adverse events;
- whether it ought to have enhanced powers to recall and/or cancel devices; and
- the feasibility of requiring a Unique Device Identifier on each device to allow for the tracking and traceability of devices.
Importantly, the TGA is also assessing options to increase the frequency of inspections of manufacturers of certain high risk devices and new onsite auditing of adverse event reporting.
Strategy 3: Provide more information to patients about the devices they use
In response to recent publicity about the safety of medical devices and the lack of public awareness about the regulatory framework for such devices, the TGA will consult on options to:
- raise public awareness about the medical devices regulatory system, including how regulatory decisions are made and ensuring the adequate provision of information to consumers (eg. requirements for manufacturers to provide implant cards for implanted medical devices will be more widely publicised and monitored for compliance);
- publish more information about clinical evidence, incident reports, inspection reports and regulatory action taken by the TGA to increase transparency; and
- establish strategies to inform consumers about medical devices, especially those which are high risk.
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