Does not support due to the potentially enormous increase in regulatory burden. The discussion paper and the review do not provide evidence of regulatory failure in higher risk devices. Doubts if the TGA will have sufficient resources to undertake the increase in assessments leading to market delays. The potential burden of increased fees per device is estimated to be 8 fold for Class III and AIMD implants. It is also unclear if some approved products will be covered by 2B or whether they can be accepted using CE Mark certification as in 2A and which mechanisms will be implemented to avoid a second round of change for joint implants.
Australian Dental Association Inc (ADA)
Australian Dental Industry Association Inc (ADIA)
Minimal impact on the Australian dental industry, however support.
Australian Health Insurance Association (AHIA)
Support- Periodic reviews should also align with private health concerns as a number of devices and procedures occur primarily in this setting. Include spinal prostheses as Class III devices.
Australian Orthopaedic Association Limited
Supports prostheses issued with an EC certificate or equivalent from an overseas regulatory body requiring confirmation of the data provided, by a clinical advisory body. Agrees with a transition period however suggests a reduction to six to twelve months and suggests clinical advisory body review of all applications once the date of change is announced to avoid the supply of joint implants into Australia that are unacceptable in other countries and Europe. Also suggest that variations must initiate New Application status in order to capture ‘look alike ‘prostheses as prostheses come off patent.
Baxter Healthcare Pty Limited
Support for new implantable devices seeking registration. The cost for requiring existing implantable devices would be a heavy burden.
BIOTRONIK Australia Pty Ltd
Suggests that proposal 2B(i) be amended to require a TGA conformity assessment certificate to also be issued for all Class III/AIMD intended for long term use unless their conformity assessment has been assessed by a Notified Body which has been approved for the purpose of the European Community Mutual Recognition Agreement.
Changes would lead to approx3.5 million dollars in extra cost to BIOTRONIK AUSTRALIA PTY LTD given the majority of their devices are Class III and AIMDs.
Also question the TGA’s ability to source enough staff to clear the back log.
Suggest applying a transition period of four years after the commencement of the new regulations to new products intended for introduction to the market.
BORG Dental (Bordent Pty Ltd)
Do not support. Will have significant impact on the dental industry. Impost of an audit cost will impact on the viability of the devices, restrict range, availability and promotional viability and lead to increased costs to the consumer.
Do not support. Significant impact on the dental industry leading to increased costs to professionals and consumers. Restrict the range, availability and promotional viability.
CareFusion Australia & New Zealand
This is a positive initiative.
Carl Zeiss Vision
This would be cost prohibitive, especially if site visits were required at manufacturing facilities in Europe and the USA. Requires further clarification of the TGA’s extent of this proposal, including full assessment fees.
Questions if TGA has enough resourcing to undertake this leading to further delays and costs for new products with possible establishment of an assessor base for similar to the NB competence levels the proposal is trying to overcome. Additional cost, resource and time burden would discourage new and existing applications. Costs to ConMed Corporation based on current Class III inclusions > $1,000,000 which includes TGA CA Fees and Charges, TGA travel costs, surveillance costs (5 years), and design examination fees and charges. Suggest minimum 12 month transition.
Consumers Health Forum of Australia (CHF)
Welcomes improvements to implant classification. Support provided all of proposal 2 goes forward.
Would like to see the scope expanded to include IPL and laser machines. Also suggest that the TGA work with Government through the COAG process to establish a national regulatory framework for the use of IPLs and laser machines.
Critical Dental Pty Limited
Dentalife Pty Ltd
Dentaurum Australia Pty Limited
Dentsply (Australia) Pty Ltd
Supports the change subject to this only applying to medical devices covered by classification rules 3.4, 5.2, 5.7, and 5.9. Any others should be subject to further consultation.
Department of Innovation, Industry, Science and Research
Concerned at any increase in regulation without demonstrated safety issues which is at odds with the HTA review.
Device Technologies Australia Pty Ltd
Does not support. Proposes that a third level of medical device application audit be created specifically to address the additional assessment requirements for Class III and AIMDs. If this proposal proceeds then suggest that the following are developed and published prior to implementation: scheduled reduced fees for conformity assessment; TGA’s business rules regarding abridgements and reductions of CA fees and assessments; and the rules for selection and on-site manufacturer facility audits. Suggest all conformity assessment application and assessment fees (including onsite audits) are reduced on a sliding scale, with the greatest reduction earlier in the transition period; and any surveillance or other associated fees incurred during the transition period are reduced.
Draeger Medical Australia Pty Ltd
Dynek Pty Ltd
It is unclear if Dynek’s products fall within the sphere of Proposal 2B. Or whether they will be accepted onto the ARTG using the CE Mark certification, in accordance with Proposal 2A. Currently pay for SGS certification and surveillance audits and the TGA’s duplication of the same activities plus will have to pay “Application Audit Fees” for four Class IIb products adding between $12,000 and $22,640 to the regulatory costs.
EBR Regulatory Affairs Consultants
TGA should guarantee that this will not affect turnaround time for reviews.
Require a longer implementation period- minimum 2 years. Would require more consultation and would like to know the costs involved. Need further evidence that this provides a sound evidence basis for the Commonwealth HTA process.
Invacare Australia Pty Ltd
Ivoclar Vivadent Pty Ltd
Johnson & Johnson Medical Pty Ltd
Agrees that increased scrutiny is appropriate for Class IIb, Class III and AIMD devices. However this should not require the introduction of level 2 application audits and TGA conformity assessment certificates. Increased oversight of international agencies and acceptance of certification from those demonstrating high standards would serve the same purpose. Concerned at the increase in resources that the TGA will require particularly when coupled with proposal 1. Concerned at the increase in fees. Propose that the TGA should: adopt the role of a designating authority for international and domestic Conformity Assessment Bodies which can demonstrate competence to evaluate all medical devices requiring pre market assessment for supply in Australia; extend the confidence building measures of Proposal 2 (c)i to include a subset of Notified Bodies from which CE certification can be accepted instead of TGA conformity assessment; continue to emphasise and maintain a robust post-market surveillance system; and proceed to full acceptance of third party conformity assessment as the basis for ARTG inclusion.
Johnson & Johnson Pacific and Vision Care Australia
Magic Mobility (Red Milawa Pty Ltd)
MAQUET Australia Pty Ltd
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
Medical Technology Association of Australia (MTAA)
Recommends that TGA issue a conformity assessment certificate on the basis of a Level 2 application audit and review of a design examination report.
Medtronic Australasia Pty Ltd
This proposal will require an additional $12.5 million in re-registration costs for Medtronic Australasia Pty Ltd to have products already on the ARTG go through a new conformity assessment. These products have already gone through a level 2 application audit and have conformity assessment evidence from a notified body. No evidence to suggest a level 2 application audit has failed to stop unsafe devices entering the market. Propose:
The TGA continues with Level 2 application audits for all implantable class III and AIMDs but condition of inclusion on the ARTG is the issue of a Certificate of Review which expires after 5 years and requires the TGA to do an application review, including:
Updated design examination (Annex II-4) certificate and design;
Risk management file; and
Or Abridged conformity assessment should the TGA proceed and that the TGA consider conformity assessments from other GHTF members such as PMA Approval USA and Health Canada.
Does not support. This will result in additional fees and longer approval times. Would require evidence to support that the current approval process has resulted in adverse performance and/or safety outcomes for patients. This reform introduces duplication of regulatory authority assessments. If it does proceed then recommends a grandfather clause.
Otto Bock Australia Pty Ltd
Paragon Therapeutic Technologies Pty Ltd (PTT)
Supports for all new products. Suggest that all Class III products which have already undergone a Level 2 audit should not be subject to a new conformity assessment audit as the relevant data has already been assessed by the TGA. These products should automatically receive a conformity assessment certificate for the existing products and if necessary only need to provide the latest Notified Body report, updated risk and clinical evidence reports. Requiring further information will significantly increase TGA’s workload and cause delays in the assessment. Transition period of 4 years is acceptable for existing Class III devices. The consultation paper did not identify the periodic review or renewal period to be applied to the Conformity Assessment Certificate and how it will be assessed.
Pfizer Australia Pty Ltd
Queensland Health- Clinical and Statewide Services Division
Queensland Health– Chief Health Officer
Queensland Health– Centre for Healthcare Improvement
No comment as it is not applicable if the proposal is restricted to implantable medical devices.
Does not support. TGA should explore ways to streamline the existing assessment system particularly for products that already have CE marks. Current approval times and processes are too onerous and replicate assessment carried out by the EU notified body resulting in significant delays. The TGA could refocus its role to verification of the EU assessment by way of Application Audit and review of the EU design examination report.
Difficult to justify that all new and old devices undergo a separate additional Conformity Assessment so that the TGA can issue independent certification. Recommend that the TGA request additional information during the application assessment. The increased workload to the TGA would increase approval times causing delays to market. Recommend not requiring a conformity assessment certificate for any of the devices captured under proposal 1 instead require them to undergo a Level 2 application audit and a review of the summary technical file.
The Pharmacy Guild of Australia
Whiteley Corporation Pty Ltd
William Green Pty Ltd
Zimmer Pty Ltd
Requires renewal of existing ARTG entries. Concerned applications for new products will be held up during the transition process. Propose TGA consider a risk management approach and review only higher risk devices and novel/innovative products. Propose considering an abridged Conformity Assessment Route and Full Conformity Assessment Route such as in Singapore.