Reforms in the medical devices regulatory framework: Overview of submissions

11 February 2011

Background

On 2 November 2010, the TGA released a discussion paper on proposed reforms to the medical devices regulatory framework.

The paper addressed Recommendation 8 of the Review of Health Technology Assessment (HTA) in Australia, released in February 2010, and in particular, the recommendations that the TGA should

• Respond to issues raised in the consultations regarding third party conformity assessment by July 2010; and
• Increase the rigour of regulatory assessment of higher risk medical devices by 2011 to ensure an appropriate level of evidential review is undertaken to ensure safety, quality and efficacy of these devices prior to entry onto the Australian Register of Therapeutic Goods and to provide a sound evidence basis for Commonwealth HTA processes.

The TGA invited submissions, views and input from all interested parties by close of business on Friday 17 December 2010. A total of 77 submissions were received and are available at: Reforms in the medical devices regulatory framework: Submissions received

A summary table of comments for each proposal is also available at: Reforms in the medical devices regulatory framework: Summary table of submissions

Overview of comments

Overall comments on each proposal are summarised below:

Proposal 1: Reclassification of joint replacement implants

The majority of respondents (56) had no comment. These were largely companies which would not be affected by the proposal. Of the 22 who did comment, 19 either supported the proposal, or signalled acceptance; several of these had comments. One stated that the proposal did not affect their company, but raised the issue of contractually agreed pricing which will affect the ability to pass on costs. Two did not support the proposal.

Of those in support or accepting, three (industry) submissions supported the up-classification of total joints, but not partial joints, whereas one (AHIA) recommended inclusion of an expanded scope of devices, and one (QLD Health) questioned the omission of ancillary components from the proposal. Two (MTAA supported by AdvaMed) recommended a later implementation of the requirements for partial joints. Four submissions supported a longer transition period than the two years proposed, whereas the Australian Orthopaedic Association (AOA) recommended a shorter transition period. One submission supported the “grandfathering” of existing entries, rather than re-assessment; this was not supported by the AOA. Three submissions raised the issue of ensuring the supply of revision components for older implants. Various issues of TGA workload, time and cost to market and details around ARTG entry were also raised in individual submissions.

Of the two submissions that did not support the proposal, one argued that post-market surveillance was an effective measure. The other proposed that up-classification be done on a product-by-product basis, with consideration being given to the reasons for revision.

Proposal 2: Third party assessment bodies and supporting reforms

Proposal 2A – Use of third party assessment bodies for Australian manufacturers

Again the majority of respondents (46) had no comment. Thirty (30) submissions supported the proposal; although most gave unqualified support, several had comments. One did not support the proposal.

Two expressed concern that linking this proposal to later proposals for a greater regulatory oversight of high risk devices would result in no benefit for a small number of Australian manufacturers.

One (Ausbiotech) expressed concern that linking the proposal with other reforms will result in additional delays. However, the Consumers Health Forum was of the opinion that the reform should be implemented in conjunction with the other proposals. One other submission stated that the process of recognition of third party bodies operating in Australia was crucial to the implementation of this proposal.

One stated that the timing of implementation should coincide with the approval process for third parties operating in Australia to prevent the situation where a company uses a 3rd party body that is later not approved.

Four submissions had questions or comments on the process for assessment of third party bodies; one (ACCORD) recommended that this process be undertaken by the National Association of Testing Authorities (NATA).

The one submission which did not support the proposal stated that it was inconsistent with Recommendation 8 of the HTA Review.

Proposal 2B(i) – requiring a conformity assessment certificate issued by the TGA for all Class III implantable devices and AIMDs

Fifty (50) respondents had no comment. These were largely companies supplying lower risk medical devices on which the proposal does not impact.

Fourteen (14) submissions supported the proposal, or gave qualified support. Two supported the proposal for new applications only and did not support a review of those products already on the ARTG. Four supported an abridged assessment process.

Eleven (11) submissions did not support the proposal, citing significantly higher costs, with subsequent reduced availability of devices, and concerns over lack of TGA resources. Ausbiotech raised concerns about an increase in regulatory burden. Five had alternative proposals for responding to the perceived need for a higher level of regulatory oversight; one suggested a new level of application audit to review the process undertaken in Europe, one considered that the need could be met by a stronger level of oversight of third party bodies. Four considered that there was no evidence to support a need for change.

Two respondents required further information on the proposal.

Proposal 2B(ii) – requiring an application audit for applications for Class IIb implantable devices

Forty-one (41) respondents had no comment.

Fourteen (14) submissions supported or accepted the proposal. One (the AHIA) supported extending the proposal to accessories to some devices. MTAA (supported by AdvaMed) recommended expanding the acceptance of products based on Application Audit to products approved by the US FDA and Health Canada. One submission proposed a slightly abridged Application Audit process. Two supported the process for new applications only. Some supporting respondents expressed concerns around cost and the increased TGA workload.

Eighteen (18) submissions did not support the proposal. Again the reasons revolved around significantly increased cost, time to market and reduced access to some affected devices. The dental industry was united in their concerns. ADIA suggested that a risk management approach be taken whereby increased regulatory oversight is only implemented for types of medical devices subject to safety concerns. One submission considered increased oversight of overseas certification bodies would achieve the proposed aim.

The four remaining submissions had general comments around Proposal 2; three of these expressed concern over costs and timing, and increased regulatory burden, but did not specifically oppose the proposal. The fourth (AOA) supported review of devices in Australia by clinical experts.

The Cosmetic Physicians Society of Australia supported Proposal 2 in general, but in particular an increased scope, to cover Intense Pulsed Light (IPL) devices and laser devices (currently IIa or IIb devices).

Proposal 2C(i) – confidence building for EU Notified Bodies designated under the MRA

Thirty-nine (39) respondents had no comment on this proposal.

Thirty (30) submissions supported the proposal, although several expressed conditional support. Ausbiotech stated that industry expects this reform to be implemented quickly and suggested that the process start with those Notified Bodies already designated under the current MRA, and that TGA take its accumulated experience into account. This approach was also supported by other respondents. Two did not support the option of only allowing access for overseas manufactured products by use of an MRA certificate, although one supported this approach. One proposed extending the provisions of the MRA outside the country of origin clause. One suggested that the TGA participate in the Europe Notified Bodies Operation Group process to undertake confidence building, and model the certification process on the Joint Accreditation System of Australia and New Zealand (JAS-ANZ) process. Respondents from the IVD industry proposed that inclusion of IVDs in the MRA not take place until a review of IVD legislation in the EU has taken place (expected to be 2015).

The Department of Innovation, Industry, Science and Research strongly supported the proposal, but recommended that the TGA develop criteria for assessment of the third party bodies which could be used to also assess third party bodies under future bilateral agreements and in the Australian context.

Eight respondents did not support the proposal. One questioned the need for an MRA at all, whilst another stated that the need for further confidence building had not been demonstrated, and that the MRA should be extended to include currently excluded devices. Two recommended that the TGA provide a clear objective for the confidence building.

Four submissions (all from the dental industry), expressed concern about the TGA’s financial commitment to the process; one recommended a cost benefit study. Other submissions from dental industry members stated that they were unclear on the reason for the proposal.

Several companies had concerns over the implications if companies were not certified by an MRA partner, and one stated that the TGA should use its experience over the years since the framework was implemented to determine competency.

Proposal 2C(ii) – Recognising Australian third party assessment bodies

Forty-nine (49) respondents had no comment on this proposal.

Twenty-six (26) were clearly in support. Two had comments which could be construed as being in support, but were not explicit.

There was no opposition to the proposal.

Respondents stated that the proposal will increase flexibility for Australian manufacturers and increase competition. Ten submissions supported the concept of TGA taking on the role of designating third party bodies in Australia, although three proposed that independent bodies such as JAS-ANZ might take on the role. Three noted a possible conflict of interest if the TGA were to retain both roles of undertaking conformity assessment of manufacturers and accrediting third parties. Three recommended that TGA take on the role of accreditation body, but cease to perform conformity assessments. Several questioned the need for third party bodies to be based in Australia. Two stated the importance of publicly available criteria against which third party bodies would be assessed.

The Department of Innovation, Industry, Science and Research strongly supported the proposal and stressed the urgency of implementing this process.

Proposal 3 – Amending the way in which a medical device is included in the ARTG and enhancing identification of approved devices

Proposal 3(i) – amend the way in which a kind of medical device is included in the ARTG

Only five (5) respondents had no comment on this proposal.

Thirty-six (36) submissions supported the proposal to some degree, ranging from strong support (consumers and health care providers) to acceptance with conditions from several device suppliers. There were a number of concerns around implementation issues. These covered the level of inclusion (eg model number, product name etc), costs for addition of a new model, need for a longer transition period, regulatory burden associated with inclusion of each line item. Several supported a fee-free notification process, with no assessment of later additions for low-risk devices.

Thirty-five (35) respondents opposed the proposal or required more information. The major concerns were significantly increased compliance costs (enumerated by the ADIA), increased regulatory burden, need for a longer transition period, allowing access by competitors to a full list of a company’s approved devices, no perceived clear driver for the proposal. Several respondents considered that they needed further clarification on the proposal.

Two respondents suggested links with the National Product Catalogue to capture the required information.

Proposal 3(ii) – enhance the ability to identify devices that have been approved by the TGA for supply in Australia

This proposal required the inclusion of the ARTG number on the product labelling. Only eight (8) respondents had no comment.

Fourteen (14) respondents supported the proposal. Eight of these were submissions for consumer/healthcare professional groups, who supported the proposal as a mechanism of improving transparency and confidence of users. One was from a regulatory consultant. Five were from device suppliers, and although one stated overall support of the proposal, it raised a large number of concerns, similar to those who were not in support.

Fifty-three (53) respondents did not support the proposal. A large number of issues were raised, including:

• This is a unique Australian requirement;
• It would create a need for overseas manufacturers to have special production lines for Australia;
• The benefit does not outweigh the significant regulatory impost;
• Significantly increased costs (quantified in a number of submissions);
• It is logistically untenable;
• It would create a need for sponsors to unpack and repackage product;
• Proposal 3(i) will suffice to achieve the required aim;
• The transition period is too short;
• These products are not medicines where one ARTG number covers only one product – because an ARTG number covers “a kind of medical device” there may be several products with the same ARTG number, which is confusing for consumers;
• There is a significant risk of error in labelling and/or packaging;
• The proposal will not work for re-usable devices;
• Alternatives are for e-labelling or web-site references, RFID tags or use of the National Product Catalogue.

One further company made comment about the difficulties of space on the labels and consideration of depleting stocks of non-compliant product, but did not specifically oppose the proposal.

These concerns mirrored those expressed strongly at the consultation session.

The DIISR submission noted broad industry adverse reaction and suggested that any adverse impacts on industry from Proposal 3 could be minimised through the development of a well publicised flexible approach in consultation with industry and by being cognisant of international medical device tracking mechanisms.

Proposal 4: Publication of device product information on the TGA website

Twenty (20) submissions had no comment on this proposal.

Thirty-one (31) submissions supported or accepted the proposal, although in many cases, support was qualified. Several supported the proposal only if limited to high risk (Class III and AIMD) devices (or, in one case, Class IIb devices). One proposed that the information only be required for consumer products. There was some concern that the information could compete with information on the manufacturer’s web-site, which could cause confusion. The preferred option was for the manufacturer/sponsor to maintain the information, but if TGA were to do it, the information should be cleared by the manufacturer/sponsor. There was not generally support for publication of information on rejected applications. One stated that the proposal should be implemented at TGA’s expense.

Twenty-three (23) respondents did not support the proposal. The concerns expressed were similar to those expressed by supporting respondents. Other issues raised were:

• Would act as a default assessment and approval process for devices not undergoing a pre-market assessment process;
• Publication of information on assessed product is of little benefit when other devices under the same inclusion may not have information published;
• Increased costs to industry and delays in approvals;
• Disclosure of commercially sensitive information;
• TGA has not demonstrated a public interest driver for this proposal;
• Professional users have access to the information already; it is more cost effective for the manufacturer/sponsor to maintain the information on their own web-site;
• Proposal bears no relationship to Recommendation 8 of the HTA Review.

The three remaining submissions made comment without signalling support or opposition. The MTAA, supported by AdvaMed, recommends a small scale, voluntary, pilot trial before wider implementation.

There was general comment that more consultation is needed around this proposal.

Conclusion

The majority of submissions were from the affected industry, which was to be expected. Respondents were generally constructive in their comments, offered alternatives where opposed and in some cases, provided costing information which will help inform future decisions.

Proposal 1 and 2A were largely supported by those who commented. Proposal 2C(i) was supported to a slightly lesser extent. Proposal 2C(ii) was fully supported.

Opinion on Proposal 2B was divided, roughly equally, by those who commented.

Proposal 3 attracted by far the greatest degree of comment. Opinion on Proposal 3(i) was again divided roughly equally. Proposal 3(ii) was opposed by a large majority.

Opinion on Proposal 4 was also divided. This proposal was not well defined, as it will be informed to some extent by the current TGA transparency review. Further discussion and consultation will be required to develop this proposal.

The TGA has undertaken to prepare a response paper to the regulatory reform consultation, with proposals for progressing reforms. It is likely that reforms will be addressed in a staged approach; timing will be dependent upon the need for further consultation, the development of Regulatory Impact Statements and Cost Recovery Impact Statements and the drafting of changes to the legislation. Stakeholders will be kept fully informed during this process.

 

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