TGA proposes changes to pre-market assessment for medical devices

AusBiotech’s March industry submission addresses the Therapeutic Goods Administration’s (TGA) proposed changes to the pre-market assessment requirements for medical devices.

In its consultation paper released in January 2013, the TGA focuses on the two key elements of the premarket assessment process: conformity assessment and approval for marketing through inclusion on the Australian Register of Therapeutic Goods (ARTG). The paper detailed the following proposals:

• Proposal A: Increased scrutiny of conformity assessment as part of mandatory application audits prior to ARTG inclusion;
• Proposal B: Publication of medical device regulatory decisions; and
• Proposal C: Abolition of requirement for TGA conformity assessment for Australian manufacturers of lower class medical devices.

The AusBiotech submission commented on:

• Proposed fees for application audits: AusBiotech suggests that the opportunity be taken to review the activity-based costing of application audit fees and that industry be provided with the opportunity to provide input to such a review.
• Publication of TGA regulatory decisions: While AusBiotech strongly supports increased transparency in TGA process and decision-making, it is, however, very concerned about the possible publication of individual rejection or withdrawal decisions. There is the potential for misinterpretation of such information resulting in undermining of public confidence in medical devices supplied in Australia and in the regulatory system, and for commercial damage to the applicant, without any tangible benefit to public health or safety. AusBiotech seeks more detailed dialogue with the TGA as this proposal is further developed.
• Abolition of requirement for TGA conformity assessment for Australian manufacturers of lower risk medical devices: AusBiotech applauds the removal of mandatory requirements for TGA direct assessment of low-risk medical devices, saying this removes a longstanding inequity which has acted as a competitive obstacle to domestic Australian manufacturers with no benefit to public health. However, AusBiotech is extremely disappointed that this exemption has not been removed across the board for all Australian manufacturers. The organisation says the retention of this additional regulatory burden will disproportionately impact Australian developers and manufacturers and is a significant impediment to Australian innovation.

The full AusBiotech submission can be found here. Enquires regarding the submission may be directed to Alina Tooley, National Manager Programs at atooley@ausbiotech.org or +61 3 9828 1425.