Consultation: Comparable overseas regulators - medical devices

22 May 2017

This consultation closed on 30 June 2017.

Invitation to comment

The TGA sought comments from interested parties on the use of marketing approval for a device in an overseas market to support inclusion of the device in the Australian Register of Therapeutic Goods (ARTG).

Consultation documents

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Timetable

Documents released for consultation on Monday, 22 May 2017.

Interested parties responded by close of business Friday, 30 June 2017.

Feedback will be released following consideration of submissions. (see 'What will happen').

About the consultation

The Therapeutic Goods Administration (TGA) sought comments on the use of marketing approval by comparable overseas regulators for a device in an overseas market to support inclusion of the device in the Australian Register of Therapeutic Goods (ARTG). This included proposed criteria to identify comparable overseas regulators and mechanisms to allow consideration of such overseas marketing approvals when deciding whether a medical device should be approved for the Australian market.

We were specifically looking for feedback on criteria for identifying:

  • comparable overseas regulators to allow consideration of their market authorisation decisions; and
  • overseas designating authorities that are comparable to the TGA to allow confidence in the third parties they designate.

Content of submissions

The consultation paper included a 'questions' box at the end of each section, with prompts for stakeholders to consider. Submissions may address any, or all, of these questions directly, or address any or all issues outlined in the consultation paper, covering:

  • proposed criteria for identifying comparable overseas regulators
  • use of overseas regulatory approvals
  • implementation issues.

In addition, submissions might include:

  • Suggested improvements
  • An assessment of how the proposed change will impact on you and whether you expect your organisation may use this pathway.
  • What do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits. This is important - the TGA is required to quantify the regulatory impact (burden and/or savings) of any proposed changes.

Enquiries

Any questions relating to submissions should be directed to the Director, Business Improvement and Support Section by email to or by telephone to our Medical Devices information line on 1800 020 65302.

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website. Once finalised, the comparable overseas regulator criteria and implementation arrangements will be published on the TGA website.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
    • Seek feedback about how the consultation was undertaken.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
  • More information on consultations and privacy is included in the submission form and on our website.

More information

Further information on the Government's response to the MMDR recommendations is available at Medicines and Medical Devices Regulation review.