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Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices
Version 1.0, December 2019 - OBPR reference: 24680
Implementation and evaluation
The implementation of the proposed reforms would require a significant education effort from the TGA. This would include engaging with all affected stakeholders in a range of fora, and developing guidance materials targeted for the different groups. The consultation period for this work, which commenced in 2017, has already resulted in increased understanding of affected stakeholders.
The proposed implementation trajectory begins with the proposed reforms coming into effect on 25 August 2020. Medical devices that are being supplied in Australia prior to this commencement date, and that would be affected by the proposed reforms, would have the benefit of a transition period as described below.
When designing the implementation and considering the transition approach, the TGA took the following considerations into account:
- The need to implement the changes as quickly as reasonable, whilst keeping in mind any additional regulatory burden the changes will impose;
- Wherever possible aligning new reporting requirements with existing time frames (so for example, manufacturers of custom-made medical devices are required to notify TGA within two (2) months of commencing supply, and annual reporting timeframes might be aligned to this initial notification date); and
- Allowing reasonable time for those manufacturers that are required to obtain full registration and compliance for their devices.
Currently included medical devices
All medical devices that are included in the ARTG prior to 25 August 2020 and that are subject to re-classification under the proposed reforms would be considered to be transitional devices. The current ARTG entry would allow continued supply until 1 November2024 if the following requirement for notification to the Secretary is followed:
The sponsor of a transitional medical device notifies the Secretary prior to 25 February 2021 of:
- the ARTG number;
- the unique product identifier of all medical devices supplied under that number; and
- which devices would require new ARTG inclusions at the end of the transition period.
The manufacturers and sponsors of these medical devices would have until November 2024 to seek the appropriate certification for their devices and to apply for new ARTG inclusions at the re-classified level.
Custom-made medical devices
The proposed requirements for custom-made medical device manufacturers to provide the manufacturer's statement with a custom-made device, and to retain records for implantable devices for a longer period, would apply to custom-made medical devices manufactured on or after 25 August 2020.
The proposed annual reporting requirements would apply to custom-made medical devices manufactured in Australia, or imported into Australia, on or after 25 August 2020. This means that the first annual reports, for custom-made medical devices manufactured in the preceding year, would be due on 1 October 2021.
The proposed ability for the TGA to inspect custom-made medical device manufacturing sites would apply on or after 25 August 2020.
Patient-matched medical devices
Patient-matched medical devices are currently captured by the custom-made medical device definition. The exemption from the requirement to be included in the ARTG for patient-matched devices that are currently considered to be custom-made devices, and are notified to the TGA in the custom-made data repository by 25 August 2020, would remain in force until 1 November 2024 for those devices that meet the following condition:
The sponsor or Australian manufacturer of a patient-matched medical device that has been notified to the TGA as a custom-made medical device prior to 25 August 2020, notifies the Secretary in writing of the following before 25 February 2021:
- the name and address of the sponsor;
- the name and address of the manufacturer;
- the device nomenclature system code for the device;
- the medical device classification of the device; and
- the unique product identifier of the device.
Such devices would need to be included in the ARTG before 1 November 2024.
Adaptable medical devices
The new definition and clarification of requirements for not alter existing regulatory requirements. Advice to relevant stakeholders will be required under transitional arrangements (such as amended guidance).
The purpose of the evaluation will be to assess the impact of the regulatory changes, whether the benefits have been realised, the impact on key stakeholders, and patient safety. The evaluation approach, questions and data requirements will be defined and agreed prior to implementation in order to ensure that appropriate data is captured to facilitate the evaluation and communicate the approach to key stakeholders. In addition, lessons learnt from other regulatory changes will be incorporated into the implementation and evaluation processes.
Methods used for data gathering are likely to include:
- formal and informal engagement with stakeholders through consultation and bi-lateral discussions
- analysis of data held on ARTG
- analysis of calls to the TGA Information Line
Stakeholders that will be consulted as part of the evaluation will include:
- other regulators (including IMDRF)
- industry associations and peak bodies
- industry-manufacturers and sponsors
- health insurers
- patients and consumers
- other governments, the Department of Health, states and territories
Questions that the evaluation may consider or address include:
- Did the increase in regulatory scope encompass all of the anticipated devices/scenarios?
- Which stakeholders and stakeholder groups did the TGA expect to be impacted by the changes, and did this align with the actual results? For example, did the organisations that now are regulated conform to the regulatory requirements?
- How effective were the communication and education methods that were employed prior to, and during the implementation?
- How many devices are now included in the ARTG as a result of the changes?
- How many hospitals registered medical device production systems (MDPS)?
- What was the number of adverse events or recalls involving devices that are now registered on the Australian Therapeutic Goods Register (ARTG)?
- Did all of the manufacturers/sponsors that indicated they would seek registration complete the registration process?
- Were there any unintended consequences for patients or the hospital system? If so, what were they?
- Were there any unintended consequences for manufacturers or sponsors? If so what were they?
- Did the regulatory burden align with the estimates? If not, where did they differ?
- Was there a perceived change in consumer confidence in the safety and performance of medical devices as a result of the changes?
- How many inspections did the TGA carry out? What were the overall results of those inspections?
- What have the impacts been on the broader community - for example has this promoted the growth of Australian manufacturers and innovation in this area?
- What were the impacts on the manufacturing of medical devices that include human-origin material?
While many aspects of the evaluation will be conducted on an ongoing basis (for example, through the forums and regular stakeholder meetings the TGA conducts and participates in), the TGA anticipates two key formal evaluation timeframes.
The first will be around the initial implementation, and likely to follow the first date for annual reporting which is 1 October 2021. The results of the evaluation would therefore be likely to be released in Q1 2022.
The second would be as a follow up to assess the inclusion of patient-matched devices in ARTG. The current proposed implementation deadline for inclusion is 1 November 2024 which means the evaluation results are likely to be released in early 2025.