proposed amendments to the regulatory model and will continue to occur throughout the implementation phase. The table below summarises how each proposed option addresses the key issues identified in the Problem section above and the objectives identified in the section above: Option 1 Option 2 Option 3 Key issues (as outlined in the section from page 12) Increased level of premarket scrutiny AIMD and Class III implantable Not addressed Level 3 audit Expanded requirement for TGA conformity assessment Class IIb implantable Not addressed Expanded mandatory audit requirement Expanded mandatory audit requirement Transparency of decision making Not addressed Publication of TGA decisions Publication of TGA decisions Requirements for TGA conformity assessment for Australian manufacturers Not addressed Abolition of requirement Abolition of requirement Objectives (as outlined in the section from page 14) Primary objective: greater assurance that higher risk medical devices approved do not compromise public health and safety Not addressed Level 3 audit and expanded mandatory audit requirement Expanded requirement for TGA conformity assessment Secondary objectives: (a) timely availability of medical devices No changes to timeframes for availability Audits will extend times frames for targeted devices (weeks to months) TGA conformity assessment will extend times frames for targeted devices (months to years) (b) minimising regulatory burden and costs No changes to regulatory burden and no additional Increases regulatory burden and significant additional costs Greater increase to regulatory burden and very significant additional costs
Attachment D: Summary of consultation on changes to premarket assessment requirements for medical devices The following summaries submissions made in response to the consultation paper Changes to premarket assessment requirements for medical devices. The paper was released on 14 January 2013, and was open for comment until 15 March 2013 Stakeholder Stakeholder comments TGA Comments Proposal A: Increased scrutiny of conformity assessment as part of mandatory application audits to ARTG inclusion Support AMS Laboratories Pty Ltd Disinfectants separated into high level (sterilants and enter body orifice), intermediate level and low level. Sterilants and high level disinfectants= level 2 audit, intermediate and low level disinfectants= level 1 audit. This is not expected to be a burden as few new applications will be received for these products. In response to consultation feedback the proposal to reduce audits of disinfectants from a Level 2 to a Level 1 audit has been modified. Level 2 audits will be maintained for liquid disinfectants, with Level 1 audits for hardware such as autoclaves. This allows for a microbiological assessment of liquid disinfectants. AusBiotech List of targeted devices in paper is appropriate and should be continually reviewed. Concerned of 1 audit for MRA applications when could direct resources to post market audits. Audits of MRA certificates to be removed once confidence building occurred. TGA publish formal plan of confidence building activities Concerns of backlog potential with level 3 audit. Costing needs review to truly reflect work put into audits. Clear timeframes for audits and penalties to the TGA if not compliant. Under the proposed arrangements MRA certificates, which are issued to Australian regulatory requirements, will continue to be treated as TGA certificates are (ie no mandatory audit). Under the amended MRA notified bodies are unable to issue MRA certificates for Class III devices until confidence building is undertaken. Existing MRA certificates continue to be valid until their expiration date. After expiration manufacturers may use notified body certification for these devices but it will be subject to audit until such confidence building occurs. See <> for more details.
William A Cook Australia Pty Ltd Consult company before releasing information. Follow similar guidelines to the FDA. Global Orthopaedic Technology Information not currently released on public ARTG summary as it is commercial in confidence. Rejections be used by competitors as a marketing tool. Information may be accidently released when not to. All relevant information already included in public ARTG summary. Integra Neurosciences Pty Ltd No health and safety benefit of publicising unsuccessful decisions. Name withheld at submitters request Successful III, AIMD and Class IIb implantable application decisions publicised only. Do not include automatic entries, “interesting products”, unsuccessful decisions, and conformity assessment decisions. Name withheld at submitters request Approval decisions for application for inclusion only. No benefit to public if rejections are published. Concerns that publication will delay ARTG inclusion. Clarification required if this is similar to AusPAR. Name withheld at submitters request Class III, AIMD, and Class IIb implantable to be publicised, if rejected- only information on safety and efficacy to be published for rejected applications. If publish low risk decisions- only successful applications.
Medical Technology Association of New Zealand Abolish TGA conformity assessment for all classes of medical devices to prevent disadvantage to Australian companies. Option 2 Proposal C now proposed the abolition of the requirement for TGA conformity assessment for all Australian manufacturers Professor Guy Ludbrook Success of the proposal depends on quality of overseas conformity assessment For this reason Proposal A and Proposal C are linked. Proposal A provides assurance in the conformity assessment of higher risk devices. This, together with MRA confidence building to be undertaken during 2014 and 2015, provides greater premarket scrutiny of higher risk devices (whether manufactured in Australian or overseas) which enables this change for Australian manufacturers. ResMed Ltd Clarification required whether this will prevent manufactures obtaining quality system certification from the TGA- thus impacting supply in Southeast Asia and American countries. Supportive of these changes for all classes of device. All types of conformity assessment certificates will still be offered by the TGA. Stryker Pacific Supports- Make use of Notified Bodies ASAP William A Cook Australia Pty Ltd Should extend to Class III, AIMD and Class IIb implantable devices as well and then undergo a Level 3 application audit. Option 2 Proposal C now proposed the abolition of the requirement for TGA conformity assessment for all Australian manufacturers. Manufacturers relying on EU certification are subject to greater when applying for inclusion on the ARTG than those holding TGA or MRA conformity assessment certification, and this may include audit requirements. Name withheld at submitters request Supports proposal as is
(i) Class III and AIMD implantable devices require a TGA conformity assessment certificate to be issued Proposal A – introduction of Level 3 audit to assess evidence of conformity (including new fee) Option 2 – Proposal A - new Level 3 audit to assess evidence of conformity (including new fee) The initial proposal for TGA conformity assessment for all Class III implantable and AIMD medical devices has been replaced with the Level 3 audit proposal (ii) Expanding the Class IIb implantable devices to be selected for mandatory auditing Proposal A – expanded targeting of mandatory audits to all Class IIb implantable and long term surgically invasive medical devices. Option 2 – Proposal A - expanded targeting of mandatory audits for targeted devices (new regulatory instrument proposed) Though not identical, this option is a direct progression from the 2010 proposal to select Class IIb implantable devices for mandatory audit Proposal 2C Recognition of third party assessment bodies The TGA will further develop these proposals in consultation with stakeholders and provide advice to Government. (i) Confidence building for EU notified bodies designated under the MRA This option has been overtaken by the update of the MRA and confidence building is being progressed in that context (ii) Recognising Australian third party assessment bodies This option has been overtaken by the proposed EU notified reforms. Immediate issues are addressed by the Option 2, Proposal audit requirements.