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Regulation impact statement: Changes to premarket assessment requirements for medical devices
Implementation and review
It is proposed that the proposed arrangements come into effect on 1 July 2015 for the following reasons:
- significant steps in confidence building with notified bodies in 2013 and 2014 will have been completed (noting that option 2 allows established confidence building activities to be strengthened and maintained).
- it coincides with the start of the financial year where application and application audit fees are adjusted due to indexation.
- it allows sufficient time for TGA to consult on implementation details with stakeholders and finalise transition arrangements.
The TGA proposes to implement the proposal changes to premarket assessment requirements for medical devices in the following way:
- Through an amendment to the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods (Charges) Regulations 1990, implemented on 1 July 2015.
- A two year transition period is proposed for the publication of information relating to TGA decisions in order to stagger this proposal as outlined below.
- It is expected that all aspects of the proposal to change premarket assessment for medical devices will be implemented by 1 July 2017.
|Decision to be published||Publication date|
|Applications for inclusion in the ARTG - Higher Risk Devices: relating to Class III, AIMD, some Class IIb implantable or long term surgically invasive medical devices and Class 4 IVDs||Successful applications||1 July 2015|
|Unsuccessful applications (where the rejection relates to issues with safety and/or efficacy of the device)||1 January 2016|
|Conformity assessment applications – Higher Risk Devices: relating to Class III, AIMD, Class IIb implantable or some long term surgically invasive medical devices and Class 4 IVDs||Successful applications||1 January 2016|
|Unsuccessful applications (where the rejection relates to issues with safety and/or efficacy of the device)||1 July 2016|
|Applications for inclusion in the ARTG - Lower Risk Devices: relating to Class I Measurement, Class I sterile, Class IIa, Class IIb medical devices and Class 3 and Class 2 IVDs||Successful applications||1 July 2016|
|Unsuccessful applications (where the rejection relates to issues with safety and/or efficacy of the device)||1 January 2017|
|Conformity assessment applications - Lower Risk Devices: relating to Class I Measurement, Class I sterile, Class IIa, and Class IIb medical devices||Successful applications||1 January 2017|
|1 July 2017|
- Implementation for decisions on conformity assessment and ARTG inclusion has been staggered as these are separate application types, with different legislative frameworks and processes. Delaying the publication of negative decisions aims to ensure all appeals processes are exhausted before publication occurs.
- From 1 July 2015, it is expected that Australian manufacturers can choose whether or not to submit conformity assessment applications with the TGA for all medical devices other than Class 4 IVDs.
- From 1 July 2015, applications selected for mandatory audit will be charged a fee commensurate with the level of assessment being conducted under the audit.
- TGA will consult with stakeholders on:
- Implementation details
- A communication strategy
- Guidance material development.
- The proposal will be continually monitored throughout the transition period and post implementation to ensure that the risk based approach to medical device regulation is consistent with international standards and emerging technology and literature.
- In order to maintain the current best regulatory practice it is proposed that the list of medical devices mandated for the application audit instrument would be reviewed on an ongoing basis, in consultation with stakeholders and amended. However, the list would be amended more frequently, where required, to address emerging issues, post market information such as recalls and current literature findings in a timely manner.
- Finally, the indexation of application and application audit fees will continue to be monitored on an annual basis to ensure that the Australian public has timely and affordable access to medical devices and that application fees reflect the level of regulatory oversight provided to the product.
Transition arrangements can be complex and therefore it is proposed that these be subject to further consultation. However, the preliminary proposal is that:
- applications for ARTG inclusion submitted prior to 1 July 2015 but for which a decision has not yet been made are not subjected to the new arrangements under proposal A and C commencing 1 July 2015
- Information not to be published for any application submitted before 1 July 2015.