TGA Release Update Regarding Proposed Regulatory Framework Reforms

TGA Release Update Regarding Proposed Regulatory Framework Reforms

The TGA proposed regulatory reforms during October 2010 in response to the Australian Government Health Technology Assessment Review (HTA) and after considerable consultation further information has been released. The announced reforms will have an effect on almost all medical device manufacturers and sponsors placing medical devices on the market in Australia. Read on to see how the reforms affect you.

Proposal 1: The reclassification of load bearing joints – class IIb to class III

The TGA have decided to implement this proposal based on data obtained from the Australian National Joint Replacement Registry (NJRR). This change will take place via amendment to the Therapeutic Goods (Medical Device) Regulations 2002 and will include a 2 year transition period commencing 1 July 2012. Sponsors of existing class IIb devices will need to submit new device applications to include their product(s) as class III devices and will of course require the supporting certification (CE Marking and Design Examination certificates). The TGA will not complete application audits on these submitted device applications to ensure uninterrupted access to applicable devices.  Finally in an unprecedented move, the TGA will waive the device application fee if the application is submitted within the first year of the transition period (before July 1 2013), encouraging manufacturers to update requirements sooner.

Proposal 2: Third party assessment bodies and implantable medical devices

This proposal included use of third party assessment bodies for Australian manufacturers, an increase of post market security for implantable medical devices, and a confidence building and recognition of third party assessment bodies. The TGA have advised this proposal remains under consideration and further consultation will occur, a somewhat disappointing result for Australian manufacturers.

Proposal 3(i): The way in which medical devices are included on the ARTG

The TGA will implement the proposal to include product name details in ARTG inclusions. The proposal, designed to improve TGA’s ability to quickly identify and recall medical devices, will be implemented again through amendment to the Therapeutic Goods (Medical Device) Regulations 2002. All ARTG inclusions will need to include product name details (product model number or trade name) and will be subject to a transition period of 2 years commencing 1 July 2012.  The TGA have advised that they will also consider imposing conditions on all ARTG entries to ensure information included is suitably maintained. At this stage it is not clear how the TGA require sponsors to make the updates. The TGA have advised that guidance regarding product name details will be released and notifications to sponsors will be provided.

Proposal 3(ii): Enhance the ability to identify devices that have been approved by the TGA

The TGA have advised this proposal is being met by the actions described above relating to proposal 3(i). The TGA acknowledge the negative reaction from respondents to the proposal based on fears of associated costs and the requirement to have Australian-only product lines.

Proposal 4: Publication of device product information on the TGA’s website

In an attempt to improve transparency and accountability of its decision making process, the TGA have advised they intend to increase the level of publicised information on their website. A decision met with mixed reaction from proposal respondents. It is hoped this reform will bring a new level of understanding of the TGA’s review processes.

KD&A will closely monitor the status of these reforms and can assist your organisation to prepare and complete required changes at any stage. The reforms, whilst in their infancy now will require action from almost all medical device sponsors with varying degrees of regulatory burden. Our advice for now….consider the new requirements, be vigilant, and stay tuned.

For further detail on the TGA released information visit: Reforms to the medical devices regulatory framework: proposals

Please contact KD&A for further details.