Consultation: Designation of Australian conformity assessment bodies for medical devices - Implementation

16 November 2016

This consultation closed on 11 January 2017.

Invitation to comment

The TGA sought comments from interested parties on the consultation paper for Designation of Australian conformity assessment bodies for medical devices.

Consultation documents

How to access a pdf or Word document

Timetable

Document released for consultation on Wednesday, 16 November 2016.

Interested parties should respond by close of business Wednesday, 11 January 2017.

Publication of consultation responses Monday, 12 June 2017.

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

About the consultation

The Expert Panel Review of Medicines and Medical Devices Regulations 2016 includes regulatory reforms for medical devices to increase flexibility in pre-market assessment processes by enabling the establishment of commercial bodies in Australia designated to undertake medical device assessments, and increasing the use of assessments from comparable overseas regulators.

In response to the reforms to establishment of commercial bodies in Australia designated to undertake medical device assessments , this paper provided, for public consultation, the proposed implementation of a system to designate bodies to undertake conformity assessment certification of medical devices, including in vitro diagnostic medical devices (IVDs) for the Australian market.

The implementation proposal is similar to that in the EU whereby there could be multiple bodies, designated by TGA, that are able to undertake conformity assessment certification within Australia. Medical devices certified by these bodies would not undergo application audit by the TGA when applying for inclusion in the ARTG. These designated bodies could potentially be designated to undertake conformity assessments for all classes of devices or for certain devices only.

Development of this pathway will require the establishment of standards for technical and clinical competence and governance (including management of conflict of interest) which such bodies would need to meet in order to be designated. The removal of the need for an application audit could mean potential saving for industry of 6 months and earlier access for consumers.

Submissions received

An overview of submissions and copies of submissions received are available at: Submissions received: Designation of Australian conformity assessment bodies for medical devices.

Enquiries

Any questions relating to submissions should be directed to the Business Improvement and Support Section, Director by email to or by telephone to our information line on 1800 020 653.

What will happen

Following consideration of submissions, a finalised implementation document will be published on the TGA website.

The TGA is currently considering all submissions that were received as part of this consultation. The TGA thanks those who took the time to make a submission and to make comments and suggestions.

Further information will be provided as it becomes available.

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.