The TGA has released its long-awaited response to the consultation on proposals for reform of pre-market assessment requirements for medical devices. The initial proposals were released for consultation in late 2010.
A number of reforms were initially proposed; the reclassification of major joint implants was implemented last year, and the TGA decided not to proceed with the proposed requirement for the ARTG number to be included on the label. It was considered that other proposals required further consideration, given the feedback to the consultation process and other actions in progress, such as the TGA Blueprint for Reform which was released in December 2011 and the two Senate inquiries into medical device regulation which were conducted in the 2011-12 period.
The proposals now released for consultation are intended to address concerns around medical device regulation by increasing the level of premarket assessment for higher risk medical devices, especially those which are implanted or inserted into the body for a significant period of time. They refine Proposals 2A, 2B and 2C in the original consultation, as well as providing more detail on the proposals for release of information in relation to device assessments.
The new proposals are:
- Increased scrutiny of conformity assessment as part of mandatory application audits prior to ARTG inclusion. This proposal would expand the current mandatory audit program undertaken by the TGA, both in terms of the medical devices targeted for audit and the level of assessment undertaken in the audit process prior to inclusion of the medical devices in the ARTG.
- This proposal will more strategically target high risk devices for application audit, to include implantable medical devices as well as surgically invasive devices intended for long term use; new devices which would be captured for mandatory application audit include those Class IIb devices that are implantable or long-term surgically invasive devices such as spinal implants, ankle joints, finger joints, peripheral vascular stents, gastric bands, or maxillofacial implants.
- It will require the review of conformity assessment documentation produced as part of the assessment and subsequent certification of a manufacturer undertaken by a European notified body – documents such as quality management system (QMS) audit reports, reports about the design of the device (design and type exam reports), and component assessment reports included in the design dossier documents.
- Introduce a new level of application audit fee to reflect the greater depth of analysis undertaken for higher risk devices. Subject to results of the Regulatory Impact Statement (RIS) and possible Cost Recovery Impact Statement (CRIS), it is anticipated that the new Level 3 audit fee would be in the range of $12,000-$15,000.
- Publication of TGA regulatory decisions. It is proposed to publish information on the regulatory decisions the TGA makes on medical devices, particularly in relation to providing information about the degree to which a medical device has been assessed prior to inclusion in the ARTG (for example whether the medical device has been audited, and the evidence considered in that audit which in practice may vary significantly between applications, or the extent to which TGA conformity assessments have been abridged).
- This proposal could also include decisions on medical devices for which applications were not approved, for which there is currently no public visibility. This proposal also progresses Transparency Review Recommendation 12 (on providing explanations of regulatory processes and adopting publication principles on the outcomes of application assessments), which was agreed to in principle in the TGA Blueprint, subject to further consultation with stakeholders.
- Abolition of requirement for TGA conformity assessment for Australian manufacturers of lower risk medical device. This proposal is the one most awaited by the medical device industry. Under this proposal Australian manufacturers would no longer be required to seek TGA conformity assessment for lower risk medical devices (covering Class I, Is, Im, IIa and IIb non-implantable), and could choose to rely on conformity assessment certification issued by European notified bodies to support applications for the inclusion of their products on the ARTG.
- This would also apply for Australian manufacturers of IVDs (covering Class 1, 2 and 3 IVDs). It is anticipated that this proposal would only be implemented in conjunction with Proposal A. The proposal outlined differs from that in relation to which the 2010 consultation occurred in that the current proposal is limited to lower risk medical devices at this time.
- Extending the removal of the requirement for Australian manufacturers to seek TGA conformity assessment for all medical devices (rather than only those lower risk medical devices) will be considered as changes proposed to the European regulatory system and under the auspices of the International Medical Device Regulators’ Forum (IMDRF) to strengthen regulatory arrangements and processes have progressed. A decision on this needs to occur prior to the implementation of the joint agency with New Zealand (ANZTPA), so it would be clear whether such a requirement would apply to New Zealand medical device manufacturers.
Submissions in relation to this Proposal Paper are invited by 15 March 2013. The paper will inform the development of more detailed changes to the regulatory framework, including a RIS, for consideration and consultation in the first half of 2013.