The TGA has released an exposure draft of a Regulation Impact Statement (RIS) on proposed changes to premarket assessment requirements for medical devices. The RIS is in response to the earlier consultation document on device reforms, released in January.
The RIS provides details on the proposed changes to legislation to accommodate the device reforms that the TGA, after consultation, has decided to implement. The TGA is seeking comment on the RIS and the final RIS will be edited based on feedback and input received. The intention is to maximise transparency by circulating a draft which is similar to the final document which will be provided to Government. In particular, some sections, such as the analysis of costs, require industry input to be completed, and so are expected to be edited substantially before the document is finalised.
The RIS amends the earlier proposals, which were:
Increased scrutiny of conformity assessment as part of mandatory application audits prior to ARTG inclusion, through targeting of mandatory audits for a wider range of high risk medical devices (but not IVDs) and increased assessment of additional evidence of conformity (but not IVDs).
Publication of medical device regulatory decisions (including IVDs)
Abolition of requirement for TGA conformity assessment for Australian manufacturers of lower Class medical devices (including IVDs).
Under the new proposals, the TGA will:
- Increase scrutiny of conformity assessment as part of mandatory application audits prior to ARTG inclusion, including two elements:
- Increase the number of products targeted for mandatory audits to include some (but not all) Class IIb implantable and long term surgically invasive devices (in addition to applications for the kinds of devices currently subject to application audit);
- Introduce a new Level 3 audit, at a cost of $22, 974, to assess additional evidence of conformity for AIMD and Class III implantable medical devices.
- Publish medical device regulatory decisions (including IVDs) in a format similar to the current Australian Public Assessment Reports for prescription medicines (AusPARs).
- Abolish requirements for TGA conformity assessment for Australian manufacturers of all medical devices except Class 4 IVDs. The outcome would be that, except for Class 4 IVDs, an Australian manufacturer could choose to have their conformity assessment certificates issued by a European notified body rather than being limited to using the TGA. Class 4 IVDs will be excluded from this proposal until the European reforms to adopt the GHTF model for IVD regulation come into force.
The new proposals A and C are intended to operate together as a package. However, it is possible to implement Proposal B in isolation from the other proposals:
- Surgically invasive and/or long term implantable medical devices, focusing on implantable and surgically invasive Class IIb devices of particular concern as opposed to capturing all Class IIb implantable devices for mandatory audit (noting that Class III and AIMDs are already captured under existing mandatory audit arrangements);
- New and novel technology: Where a new and novel technology is likely to have a significant impact on public health or where the risks have not been widely established (Class IIb and above); and/or
- Post market issues: Where devices are experiencing post market issues of concern (Class IIb and above).
The RIS also includes a summary of the comments received in relation to the initial consultation paper and discussion of what has prompted the changes to the original proposals, with a rationale for the new proposed changes, together with costings for the proposals.
Comment is invited on the RIS here. Interested parties should respond by close of business 3 June 2013.