You are here

Regulation impact statement: Changes to premarket assessment requirements for medical devices

26 June 2013

Book pagination

Consultation

Proposal Paper: Changes to premarket assessment requirements for medical devices - January to March 2013

As outlined above, on 14 January 2013 the TGA released Changes to premarket assessment requirements for medical devices: Proposal Paper, with consultation on the paper open through to 15 March 2013.

The consultation was aimed at the TGA's currently identified externals stakeholders in order to provide a comprehensive analysis of the proposal. Consultation occurred through publication of the paper on the TGA website50. It was also emailed to members of the TGA's Regulatory and Technical Consultative Forum on Medical Devices (known as RegTech), and members of the medical device reforms reference group, established to provide advice to the TGA on the Blueprint medical device reforms. The Advisory Committee on Medical Devices (ACMD) meeting 15 March 2013 also discussed the consultation proposal.

The TGA received 39 submissions from a varied stakeholder group including medical device industry (including manufacturers, importers, and suppliers), consumer groups, academics, professional bodies, healthcare professionals, engineers, regulatory consultants and government organisations. The submissions received are available on the TGA website51 and a summary of the submissions received is included at Attachment F: Summary of consultation on changes to premarket assessment requirements for medical devices.

The following graph outlines the distribution of submissions by stakeholder groups:

Figure 1 - Distribution of submissions – January to March 2013 consultation

Industry 64%, Professional Bodies 10%, Consumers 10%, Government 6%, Other 10%

As expected, various stakeholders commented on the most relevant proposals according to their area of interest, expertise and cost impact. Proposal A was commented on the most, and proposal C was least commented on. While the industry sector was not overly supportive of the proposal to introduce a Level 3 mandatory audit, it was generally supportive of the proposals relating to the publication of information relating to TGA decision making. It was very supportive of the proposal to allow for third party conformity assessment for Australian manufacturers, stating the proposal should be broadened to cover all classes of medical devices, not just low-medium risk. The remaining stakeholders were very supportive of Proposals A and B but more cautious about Proposal C.

A summary of the key comments are below:

  • Proposal A: Increased scrutiny of conformity assessment
    Mixed support. Comments included:
    • Targeting of mandatory audit:
      • Not all Class IIb implantable or long term surgically invasive devices are of significant risk and therefore it was suggested TGA consider refining that list to, for example, excluding dental implants
      • Disinfectants and sterilants should continue to undergo Level 2 audits (as the proposal suggested this drop to a Level 1 audit)
      • Concerns were raised over the quality of EU notified bodies
    • Level 3 audit:
      • Supported by consumers, who considered this provided an appropriate balance between costs to patients if adverse events occur and sponsor profits
      • Not generally supported by industry due to the increased cost and assessment time. (The MTAA submission suggested that in some cases this would result in a 693 per cent cost increase.)
  • Proposal B: Publication of information about regulatory decisions
    Majority support. Comments included:
    • Trial publication of Class IIb implantable and AIMD long term implantable Class III medical devices first
    • Only publish successful applications for inclusion in the ARTG
    • Should be similar to AusPAR
    • Concerns included:
      • Publication of confidential information
      • Publication of rejected applications for conformity assessments may damage commercial interests
      • Publication of decisions delaying ARTG inclusion
      • Publication of rejected and withdrawn decisions damaging industry reputation.
  • Proposal C: Removing the requirement for TGA conformity assessmentfor lower class devices
    Majority support. Comments included:
    • The proposal should go further and abolish TGA conformity assessment for all devices (especially after confidence building with the EU).

Top of page

Regulation Impact Statement exposure draft - May to June 2013

Further consultation was conducted between 10 May and 3 June 2013 with the release of the Regulation Impact Statement (RIS) exposure draft: changes to premarket assessment requirements for medical devices. The timeframe for response to this consultation was short (a little over three weeks) due to the time frame of providing advice to Government on these reforms by 30 June 2013, but also because the RIS exposure draft was built so closely on proposals outlined in the January to March 2013 consultation paper.

The consultation was aimed at the TGA's currently identified external stakeholders and occurred through publication of the RIS exposure draft on the TGA website52 and on the business consultation website53. A link to the consultation paper was also emailed to each submitter from the January-March 2013 consultation, representatives of Medsafe New Zealand, and to members of the Medical Device Reforms Reference Group, established to provide advice to the TGA on the Blueprint medical device reforms.

The TGA received 21 submissions, largely from a subset of those stakeholders who responded to the January to March 2013 consultation, with only two new respondents to this consultation. A summary of the submissions received is included at Attachment G: Summary of consultation on Regulation Impact Statement exposure draft.

The majority of submissions commented on Option 2, with the most substantive comments provided on Proposal A, and Proposal C the least discussed. Option 3 received no support from any of the respondents. The following graph outlines the distribution of submissions by stakeholder group:

Figure 2 - Distribution of submissions – May to June 2013 consultation

Industry 64%, Professional Bodies 10%, Consumers 10%, Government 6%, Other 10%

A summary of the key comments are below:

  • Option 1 - No immediate action: This option was not seen as viable by most respondents, who provided minimal or no comment on this option.
    • However, this option was supported by four key industry stakeholders, who argued that the problem outlined in this RIS is not sufficiently established to warrant further premarket reforms, particularly given other medical device reforms already underway. Current reforms cited included increased post market surveillance, establishing devices registries for high risk devices, the reclassification of hip, knee and shoulder joint implants and undertaking confidence building with EU notified bodies
    • A number of these respondents argued that this approach should be coupled with a shift in the TGA's role to one of a competent authority (with the TGA no longer undertaking conformity assessment work directly, but rather designating conformity assessment bodies, in parallel to European arrangements).
  • Option 2 - Changes to premarket assessment of medical devices: The various proposals under Option 2 received the majority of substantive comments provided by respondents to the consultation, as this was seen as the most likely and/or acceptable option.
    • Proposal A - Increased scrutiny of conformity assessment: Comment was mixed on this proposal. The Consumers' Health Forum expressed concern that the scope of this proposal had been narrowed, from capturing all Class IIb implantable and surgically invasive medical devices to only some. Many industry responses provided qualified discussion on the option, with concerns including:
      • requests for further consultation on Class IIb devices to be selected for audit, transparent guidelines on the rationale for selecting products for audit
      • The cost to industry of this proposal, including direct costs (fees and compliance costs such as provision of notified body reports) and incidental costs, such as delays in accessing the Australian market.
    • Proposal B - Publication of information about regulatory decisions: Support for this proposal was strong, with the majority of respondents either fully supportive, or providing qualified support. Where concerns were raised, these were similar to those in the January to March 2013 submissions. These include the publication of unsuccessful decisions, particularly where the rejection is not based on safety and efficacy (hence the modification suggested for this proposal in this RIS), and maintaining commercial in confidence information (an issue which can be addressed as part of implementation).
    • Proposal C - Removing the requirement for TGA conformity assessment for lower class devices: This proposal received very strong support from industry. The only dissenting comment was raised by the Consumers' Health Forum, expressing concern about removing this requirement given issues about of conformity assessment conducted by some EU notified bodies. However confidence building in EU notified bodies and the increased scrutiny of EU notified body conformity assessments under Proposal A should address these concerns.
  • Option 3 - Expand TGA mandatory conformity assessment for AIMD and Class III implantable medical devices and allow third party conformity assessment for other devices except Class 4 IVDs: There was a clear consensus among respondents that this option is not recommended, with no respondents supporting this option.

Footnotes

  1. <http://www.tga.gov.au/newsroom/consult-medical-devices-premarket-assessment-130114.htm>
  2. <http://www.tga.gov.au/newsroom/consult-medical-devices-premarket-assessment-130114-submissions.htm>
  3. <http://www.tga.gov.au/newsroom/consult-medical-devices-premarket-assessment-130114.htm>
  4. <https://consultation.business.gov.au/consultation/Default.aspx>

Top of page

Book pagination