Relevant industry sectors, professional and consumer groups, and individuals provided comment and input to the proposals outlined in the discussion paper Reforms in the Medical Devices Regulatory Framework. A summary table has been compiled and is available below.
The submissions received by the TGA are listed in alphabetical order of name of organisation. Please note that submission 70 was not included by request of the submitting organisation.
Summary Table of Comments Received
1 Reclassification of joint replacement implants. That a new classification rule be added to Schedule 2 of the medical device Regulations to reclassify all hip, knee and shoulder- joint replacement implants from Class IIb to Class III medical devices.
2A Use of third party assessment bodies for Australian manufacturers. That Subregulation 4.1(1) be removed from the medical device Regulations so as to no longer require Australian medical device manufacturers to hold TGA conformity assessment certification.
2B Increasing pre-market scrutiny for implantable medical devices:
(i) Devices requiring a TGA Conformity Assessment Certificate to be issued; and That Subregulation 4.1(2) of the medical device Regulationsbe amended to require a TGA conformity assessment certificate to also be issued for all Class III and AIMD implantable medical devices.
(ii) Applications to be selected for auditing. That Regulation 5.3 of the medical device Regulationsbe amended to require applications for all Class IIb implantable devices to also be selected for an application audit prior to inclusion in the ARTG.
2C Recognition of third party assessment bodies:
(i) Confidence building for EU Notified Bodies designated under the MRA; and That the TGA commence discussions with the EC over a program of confidence building with the designated Notified Bodies under the MRA, which might include sharing of product assessments and observed audits of medical device manufacturers.
(ii) Recognising Australian third party assessment bodies. That further consultation be undertaken to investigate the development of a system whereby Australian-based assessment bodies can be designated to issue conformity assessment certificates to Australian manufacturers.
3 Amending the way in which a medical device is included in the ARTG and enhancing identification of approved devices:
(i) amend the way in which a kind of device is included on the ARTG; and
Supports but suggests holding off on partial joints until the European Union Commission implements extensively and additional evidence and data can confirm that such reclassification will indeed improve patient outcomes. Suggest that the NJRR data is further analysed to allow for age and other factors that may influence relative risk before implementing changes to reclassify partial joints.
Australian Dental Association Inc (ADA)
Australian Dental Industry Association Inc (ADIA)
Australian Health Insurance Association (AHIA)
Supported, with expanded scope of devices to include spinal prostheses and ensuring a strict two-year transition period.
Australian Orthopaedic Association Limited
Supported. Believes that this reclassification will bring with it an increased assessment process of clinical evidence and recommends that an overarching committee be formed to review the applications in a timely manner. Should consist of key stakeholder groups- government, the clinical colleges, medical device and technology groups. Recommends the chair to be a suitably qualified clinician with nationally recognised clinical and managerial skills. Recommends a reduction in the transition period to six-to-twelve months to avoid Australia becoming a repository for unacceptable implants from overseas and that a clinical review of all applications is undertaken once the date of change is announced.
Concerned at any increase in regulation without demonstrated safety issues, which is at odds with the HTA review. This proposal appears to be supported by evidence from the National Joint Replacement Register.
Device Technologies Australia Pty Ltd
Does not support. Current post market surveillance is proving effective. Increasing the classification will not facilitate access to new improved technologies. If it proceeds propose an exemption for non-transitioned joint replacement components for revision only be applied and annual fees and application audit fees are waived for joint replacement implants during the transition period.
Draeger Medical Australia Pty Ltd
Dynek Pty Ltd
EBR Regulatory Affairs Consultants
This should be done product by product. Identify the root cause of the revisions being higher for total joints i.e. some patients should never have been given a total hip in the first place or is it surgical skill. TGA should guarantee that this will not affect turnaround time for reviews and need further clarification exactly how this will level the playing field.
Independent Rehabilitation Suppliers Association (IRSA)
Integra Neurosciences Pty Ltd
Invacare Australia Pty Ltd
Ivoclar Vivadent Pty Ltd
Johnson & Johnson Medical Pty Ltd
Supported but requests that the proposed two-year transition period be increased to a minimum of four years. Would like further clarification of the unique product identifiers requirement for orthopaedic implants.
Change does not affect MAQUET Australia. Comment that the majority of sponsors have agreements set for 5 years to supply at contractually agreed pricing. Any of these changes will need to be absorbed by the sponsors.
Max Boccardo Associates
Supported. Suggests that Class IIb devices be reclassified as Class IIa.
Medical Technology Association of Australia (MTAA)
Reclassification of Class IIb implantable orthopaedic joints as Class III devices be undertaken with a Level-2 application audit and then a TGA conformity assessment certificate be issued following review of the design certificate;
TGA quarantine components of superseded implantable systems retained for revision or repair procedures and accept Class IIb level certification;
Alignment of transition periods with a four year transition for the reclassification of implantable orthopaedic joints; and
A staged implementation of reclassification, starting with full joints then moving to partial joints at a later date.
Medtronic Australasia Pty Ltd
Supported. TGA needs to be aware of the increased workload and could offset this by using designated Australian Conformity Assessment Bodies.
Supported but suggests that devices already on the ARTG be ‘grandfathered’ rather than having to resubmit applications. Has implications regarding Proposal 2B.
Otto Bock Australia Pty Ltd
Paragon Therapeutic Technologies Pty Ltd (PTT)
Support total implants. Suggest that Europe does not include partial implants and including them will be contrary to the GHTF and harmonisation. Other national joint registers have not seen similar issues to that of the National Joint Replacement Registry report which lacks some key parameters of assessment that would enable the TGA to justify an up classification of partial joint replacements. Concerned that the supply of revision components for older joint systems remains unaddressed in this proposal. Use of the Special Access Scheme will result in the denial of reimbursement and will disadvantage the patient financially and may lead to this no longer being an option.
Note that an existing Class IIb entry will lead to multiple Class III applications because of the UPIs.
Unclear if ARTG number for an existing Class IIb inclusion can still be referenced for reimbursement until the transition process is complete? TGA has not indicated how long the reclassification will take creating uncertainty for the market. Suggest treat existing Class IIbs as an up classification rather than a new application and only require a Level 2 application audit.
Pfizer Australia Pty Ltd
Queensland Health- Clinical and Statewide Services Division
Questions the risk of omitting ancillary components from the higher classification leading to higher ongoing revision rates.
Queensland Health– Chief Health Officer
Support. Although concerns raised that there is assurance that the implant and related items are recognised as a complete related set or system.
Queensland Health– Centre for Healthcare Improvement
Royal Australasian College of Physicians (RACP)
RTI Biologics Inc
Seating Dynamics Australia Pty Ltd
Smith & Nephew Pty Ltd
Supports provided it matches the EU system. The additional cost to industry requires further consultation.
TGA consult with industry to add additional variants to the current approval list and provide greater flexibility in the selection of UPIs. Allows same level of visibility and reduces the number of applications assessed by the TGA reducing costs and resource requirements of the TGA. An extended transition period for partial joint replacement implants to allow manufacturers to work with the notified body and obtain the necessary documents. Recommend that the SAS be redesigned to a notification based model similar to that for custom made implants to cope with the increases.
The Pharmacy Guild of Australia
Whiteley Corporation Pty Ltd
William Green Pty Ltd
Zimmer Pty Ltd
Recommend that partial joint implants be removed from the proposal as the EU MDD can be interpreted to allow IIb classification for partial joint prosthesis which may mean some devices classified IIb in Europe will require a higher classification in Australia. Recommend the same 5 year phase in that Europe had as two years is too short considering that manufacturers must collate evidentiary data to demonstrate safety, quality and performance of the affected implants. Propose a risk managed approach to the transitioning of implants. The longer they have been on the market the less clinical evidence required. Concerned at the use of the Special Access Scheme and the loss of reimbursement. Recommend a guidance document is developed with input from all stakeholders prior to implementation. Concerned at resource implications for the TGA having flow on effects with new application processing.