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 In response to consultation feedback the proposal to reduce enter body orifice), intermediate level and low level. audits of disinfectants from a Level 2 to a Level 1 audit has been modified. Level 2 audits will be maintained for liquid Sterilants and high level disinfectants= level 2 audit, disinfectants, with Level 1 audits for hardware such as intermediate and low level disinfectants= level 1 autoclaves. This allows for a microbiological assessment of audit. This is not expected to be a burden as few new liquid disinfectants. applications will be received for these products. AusBiotech List of targeted devices in paper is appropriate and Under the proposed arrangements MRA certificates, which should be continually reviewed. are issued to Australian regulatory requirements, will continue to be treated as TGA certificates are (ie no Concerned of 1 audit for MRA applications when mandatory audit). could direct resources to post market audits. Audits of MRA certificates to be removed once confidence Under the amended MRA notified bodies are unable to issue building occurred. MRA certificates for Class III devices until confidence building is undertaken. Existing MRA certificates continue TGA publish formal plan of confidence building to be valid until their expiration date. After expiration activities manufacturers may use notified body certification for these Concerns of backlog potential with level 3 audit. devices but it will be subject to audit until such confidence Costing needs review to truly reflect work put into building occurs. See <> for more details. audits. Clear timeframes for audits and penalties to the TGA if not compliant.
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.
consult-ris-medical-devices-premarket-assessment-130510-1.docx