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Reforms to the medical devices regulatory framework: Proposals
The Government's response to the following proposals are contained in the TGA reforms: A blueprint for TGA's future.
The Australian Government Health Technology Assessment review (HTA) Review in December 2009 recommended key improvements to the way new health technologies, procedures and services are assessed in line with international best practice.
That the Therapeutic Goods Administration (TGA), in the context of international harmonisation:
increase the rigour of regulatory assessment of higher risk medical devices by 2011, to ensure an appropriate level of evidential review is undertaken to ensure safety, quality and efficacy of these devices prior to entry on the ARTG and to provide a sound evidence basis for Commonwealth HTA processes.
In response to recommendation 8c, the TGA released a discussion paper in October 2010. The TGA invited submissions from all interested parties. An overview of the 77 submissions received is available on the TGA Internet.
As a result of the comments received during the consultation process, the TGA has refined and modified its recommended reform proposals. This response should be seen as one step in the reforms process.
Legislative amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 are required to progress proposals 1 and 3(i). A start date of 1 July 2012 is anticipated, to coincide with the financial year and consequently streamline the revised fees and charges.
The TGA will release a Cost Recovery Impact Statement for comment and will also be preparing a Regulation Impact Statement for the Government.
The TGA discussion paper of October 2010 contained nine distinct proposals. These are now discussed individually after consideration of the responses received during the consultation process.
The TGA proposal
The TGA has identified a need to reclassify load bearing joints from Class IIb to Class III based on data obtained from the Australian National Joint Replacement Registry (NJRR) regarding adverse events and revision rates (the need to undergo further corrective surgery) for these types of implants. There is a need to up-classify both total and partial joints, as the data from the NJRR demonstrates that the revision rate for partial joint replacements is higher than the revision rate of total joint replacements (NJRR Annual Report 2009).
The purpose of this proposal is to increase the pre-market regulatory rigour of an implantable load bearing component of a hip, knee or shoulder joint replacement that functions in a similar way to the natural joint. Both partial and total joint replacements will be included. It does not apply to ancillary components or accessories of joint replacements, such as screws, wedges, plates or surgical instruments.
This proposal was largely supported by respondents.
The consultation process identified that there was some preference for a longer transition period. However, given that Europe has already undergone this transition, the TGA considers that a large proportion of manufacturers will already hold the required evidence (a design examination certificate). Consequently, the TGA considers that a two year period is a sufficient amount of time to transition to the new classification.
Proposed course of action
The TGA considers that the health and safety aspects of this proposal, which will increase the pre-market rigour of evidential requirements applying to hip, shoulder and knee joints, need to be balanced with the practical realities for industry to ensure that the re-classification can be implemented successfully with uninterrupted access to these important medical devices. The TGA considers that an official transition time of two years achieves a good balance to address public and industry concerns.
The TGA intends that this proposal will be implemented for devices currently included in the ARTG as follows:
- Through an amendment to the Therapeutic Goods (Medical Devices) Regulations 2002 with a two year transition period commencing from 1 July 2012.
- Sponsors of existing Class IIb devices will need to submit new applications to include these devices on the ARTG as Class III devices. This will include the requirement to have appropriate Class III certification, such as European Commission (EC) certification1. The TGA will contact affected sponsors notifying them of the new requirements.
- To enable uninterrupted access to these devices, the TGA will put in place transitional arrangements so that affected Class IIb devices already on the ARTG will not be selected for application audits when an application is made to enter these devices on the ARTG as Class III devices. Instead the TGA will review the certification information previously provided by the sponsor2.
- The TGA will waive application fees for those devices already on the ARTG that are up-classified during the first year of the transition period. Joints that are up-classified in the second year of the transition period will not receive any fee concessions.
- The re-classification will be fully operational at the cessation of the two year transition period.
- If a valid application is not received by the end of the two year transition period, the TGA will cancel all remaining affected Class IIb devices which should have been entered as Class III devices from the ARTG. The sponsor would then need to submit a new Class III application, which would undergo the usual evaluation procedures.
- It is expected that TGA will, as far as possible, identify and write to those affected sponsors approximately 6 months prior to the cessation of the transition period.
- All new applications for Class III devices, ie. non-transitioning devices, will undergo an application audit. As with any new application for inclusion in the ARTG, these products will not be able to be supplied until such assessment has been completed by the TGA and the device is included on the ARTG.
- a certificate of compliance for conformity assessment issued by a European Notified Body to enable a device to be included on the ARTG
- Applications to include certain medical devices in the ARTG must be selected for an application audit - this includes Class III medical devices that have not been assessed under the European Commission Mutual Recognition Agreement or the European Free Trade Association Mutual Recognition Agreement.)
Proposal 2: Amendments to regulatory provisions relating to third party assessment bodies and implantable medical devices
Proposal 2 consisted of three parts:
- Proposal 2A - Use of third party assessment bodies for Australian manufacturers
- Proposal 2B(i) and (ii) - Increasing pre-market scrutiny for implantable medical devices
- Proposal 2C(i) and (ii) - Confidence building and recognition of third party assessment bodies
These proposals remain under consideration and further consultation will occur on amended versions of these proposals.
The TGA proposal
This proposal will require the sponsor to nominate product names under each ARTG entry for a kind of medical device. This will improve the ability of the TGA to quickly identify and, where necessary, recall individual medical devices.
This proposal will:
- enhance the TGA's ability to monitor the safety and performance of all devices of that kind supplied in Australia
- ensure that the device being supplied under a particular inclusion is the same kind of device
- enable healthcare providers and consumers to search the ARTG to find the device model.
There was mixed support from respondents for this proposal. The major concerns raised were in relation to implementation issues and increased compliance costs.
Proposed course of action
The TGA intends to implement this proposal as follows:
- Legislative amendments will be made to the Therapeutic Goods (Medical Devices) Regulations 2002.
- All ARTG entries for medical devices will need to include Product Name details related to the product.
- The TGA will issue guidance on how Product Name is to be described on the ARTG. Product Name will be required to identify the product by model number or trade name.
- The TGA will endeavour to write to all sponsors advising them of the new requirements. This will include a new condition that the sponsor keeps the ARTG entry up-to-date and that a device is entered by the Product Name on the ARTG prior to supply on the Australian market.
- The ARTG will be updated to allow consumers and industry to search for a device on the ARTG by Product Name.
- There will be a two year transition period from 1 July 2012. Fees to amend ARTG entries will be waived during this period.
- The TGA will also consider imposing conditions on all ARTG entries to ensure that information regarding the device on the ARTG is kept up-to-date and a failure to do so would constitute a breach of a condition of inclusion and would be grounds to cancel the device from the ARTG.
Proposal 3(ii): Enhance the ability to identify devices that have been approved by the TGA for supply in Australia
The TGA is not intending to proceed with proposal 3(ii). This is because the TGA considers that proposal 3(i) can achieve the health and safety outcomes that are being sought - to increase the ability to identify devices approved by the TGA for supply in Australia - without affecting the availability of medical devices in Australia.
The TGA also acknowledges the negative reaction from respondents to this proposal, which included concern over associated costs and the requirement to have Australian-only product lines that might lead to the withdrawal of medical devices from the Australian market.
The TGA proposal In the interests of improving the transparency and accountability of its decision making processes, the TGA intends to increase the level of device product information publicised on the TGA website.
There was a mixed reaction from respondents to this proposal.
The TGA recognises that industry is concerned that there may be increased costs, or that publication of more device-related information may disclose commercially sensitive information. The aim of this proposal is not to affect the business operations of industry but rather to ensure that the public has greater access to information. Disclosure of any information by the TGA would be in accordance with its freedom of information obligations.
Proposed course of action
The TGA considers that it is important to be more transparent and will explore the possibility of posting manufacturers' Instructions for Use (or an abstract thereof) and Australian Public Assessment Reports (AUSPAR) equivalents on the TGA website in the first instance.