Strengthening the assessment of medical devices and information for consumers
A new regulatory framework for surgical mesh devices and provision of information to the consumers for all implantable medical devices was approved by the Minister for Health, the Hon Greg Hunt.
The changes are intended to maintain the alignment of the Australian regulatory framework with similar initiatives recently announced in Europe.
They are another step in the implementation of the broader regulatory reform agenda set by the Review of the Medicines and Medical Devices Regulations. In particular, the Government has accepted recommendation 20 of the Review which states that the regulation of medical devices by the Therapeutic Goods Administration (TGA) is, whenever possible, aligned with the European Union framework.
The timing proposed for implementation reflects Australian public health imperatives.
Under the proposals, from 1 December 2018, all new surgical mesh devices, including urogynaecological mesh devices, seeking approval from the TGA will need to meet the higher evidentiary requirements of a Class III medical device.
A transition period will apply for surgical mesh devices currently on the market. In light of concerns expressed by many women who have undergone surgery with an urogynaecological mesh device, a two years transition period applies for this up-classification measure from the commencement of the regulations. This means that existing urogynaecological devices will need to lodge a re-classification application no later than December 2020.
A three year transition period to December 2021 is proposed to apply for other surgical mesh devices.
The Government has also listened to concerns from consumers about the absence or only limited information being provided to inform them about the medical device implanted during surgery.
From 1 December 2018 manufacturers of all new permanently implantable devices (other than those exempted) will need to have a patient information leaflet in the TGA approved format. This summary document about the device is intended to be similar to the consumer medicines information leaflet given to the patient. A graduated transition period is proposed to apply reflecting public health imperatives: from December 2019 for urogynaecological mesh devices and December 2021 for all other permanently implantable devices.
Patient cards for implantable medical devices will also be required for all new urogynaecological mesh devices from 1 December 2018.
The TGA will work with the consumer, industry, professional clinical organisations, states and territories to co-design the format of the patient information materials so as to deliver effective and efficient information to the consumers over the lifecycle of the device.
A three-year transition period from the commencement of the new regulations to December 2021 will also be in effect for the other existing permanently implantable medical devices.
The enhanced patient information materials will contribute to better informed consumers and assist consumers and doctors in the informed consent process as well as greater traceability of the use of the device through the health system.
A tabulated summary is below.
|Up-classification||Device info leaflet||Patient implant card|
|New devices||1 Dec 2018||1 Dec 2018||1 Dec 2018|
|Existing devices||1 Dec 2020||1 Dec 2019||1 Dec 2019|
|New devices||1 Dec 2018||1 Dec 2018||1 Dec 2020|
|Existing devices||1 Dec 2021||1 Dec 2021||1 Dec 2021|
|Implantable devices (other than those exempted)|
|New devices||NA||1 Dec 2018||1 Dec 2020|
|Existing devices||NA||1 Dec 2021||1 Dec 2021|