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From 1 December 2018, manufacturers of all new permanently implantable devices (other than those exempted) will need to provide patient implant cards and have a consumer device information leaflet, as part of new consumer information requirements.
On this page: Information requirements | Transition period | Device reclassification - amendments to Prostheses list | Background
Information requirements
In consultation with the medical devices industry, the TGA has developed guidance which outlines the information requirements for patient implant cards and consumer device information leaflets. The guidance also includes recommendations for card and leaflet design to maximise the benefit of these information materials for consumers:
Electronic leaflets
Electronic leaflets may be used where it is not practical to comply with the requirement to provide these directly with the device by 1 December 2018. In this instance patients should be given a patient card with the manufacturer's website with direct links to specific information about the medical device.
Electronic leaflets (i.e. links to the leaflet on the manufacturers' website) may be appropriate where printed updates of the leaflet are not available yet.
If you are considering electronically based leaflets, care must be taken to ensure that patients are able to easily navigate the manufacturer's website and find the correct leaflet.
The TGA should be notified of the timeframe and any actions taken by the manufacturer or sponsor to comply with Regs 13A.3 when requested. This may include but is not limited to providing a risk mitigation strategy and action plan to inform patients and hospitals of where to retrieve the e-leaflet and when the paper copy will be supplied.
If directed to a leaflet on the manufacturer's website, Therapeutic Goods advertising code must be adhered to.
Note
The electronic patient information leaflet must contain the information required in Reg 13A.3. Additionally, the Therapeutic Goods Advertising Code must be met.
Transition period
The new requirements will be phased in from 1 December 2018, through to 1 December 2021. A graduated transition period applies for existing medical devices, reflecting public health imperatives. The following table summarises transition arrangements:
| Patient implant card | Device information leaflet | |
|---|---|---|
| Urogynaecological mesh | ||
| New devices | 1 December 2018 | 1 December 2018 |
| Existing devices | 1 December 2019 | 1 December 2019 |
| Implantable devices (other than those exempted) | ||
| New devices | 1 December 2020 | 1 December 2018 |
| Existing devices | 1 December 2021 | 1 December 2021 |
Device reclassification - amendments to Prostheses list
Some sponsors list their devices on the Prostheses List in order for the devices to be reimbursed by private health insurers.
When the Therapeutic Goods Administration (TGA) reclassifies a product, a new ARTG number is issued. This means that suppliers of affected products will need to update their Prostheses List listings.
Medical devices that have been reclassified from Class IIb to Class III and that are currently listed on the Prostheses List will require their listings to be to be updated in order to remain on the Prostheses List.
Failure to maintain the currency of Billing code details in the Prostheses List may result in discrepancies between private hospital records and the Prostheses List. These discrepancies may result in benefits not being paid by private health Insurers.
To update the Prostheses List with your new ARTG numbers, you will need to submit an Amendment application using the Prostheses List Management System (PLMS) for each of the affected Billing codes. When submitting an amendment application, please ensure that you clearly advise the reason for the change and include relevant supporting documents that clearly identify the required changes.
Examples of supporting documentation include:
- New ARTG certificate
- Catalogues (with any changes highlighted)
For any queries about amending your Billing code on the Prostheses list, please contact the Prostheses Hotline (02) 6289 9463 or email prostheses@health.gov.au.
Background
These new requirements are part of the TGA's ongoing work to harmonise the Australian medical devices regulatory framework with the European Union's Medical Device Regulation (EU 2017/745), which was a recommendation of the Expert Panel Review of Medicines and Medical Devices Regulation:
Recommendation Twenty
The Panel recommends that:
- The regulation of medical devices by the Australian NRA is, wherever possible, aligned with the European Union framework including in respect of the:
- Classification of medical devices;
- Essential Principles/Requirements.
- Adoption of a risk-based approach to variations to medical devices.
- Should the Australian NRA seek to apply specific requirements, there must be a clear rationale to do so.
These new requirements are also intended to address consumer information gaps (e.g. the name and type of medical device implanted) which were identified in a number of government inquiries, the most recent being the Senate Inquiry on the 'Number of women in Australia who have had transvaginal mesh implant and related matters'. This is the key reason for bringing this change into Australia ahead of the EU.
Targeted consultations were held with consumers, healthcare professionals and medical device sponsors prior to implementing the first tranche of reforms.