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Sponsor's ongoing responsibilities

11 October 2019

Sponsors who have submitted a valid application to include a medical device in the Australian Register of Therapeutic Goods (ARTG) to the TGA have certified that:

  • the products is a medical device
  • the intended purpose of the product as stated in the application form has been ascertained from the manufacturer's instructions from use, advertising material, technical documentation, and/or project label(s)
  • the device is correctly classified
  • the information included with the application is complete and correct
  • the device complies with the Essential Principles and the manufacturer has available sufficient information to substantiate that compliance with the Essential Principles or have procedures in place, including a written agreement, to ensure that such information can be obtained from the manufacturer within 20 working days
  • an appropriate conformity assessment procedure has been applied to the device
  • the sponsor has available sufficient information to substantiate the application of those conformity assessment procedures or have procedures in place to ensure that such information can be obtained from the manufacturer within 20 working days
  • any advertising material relating to the medical device complies with the TGA requirements - for more information see our Advertising Hub.
  • the device does not contain substances that are prohibited imports under the Customs Act
  • the device is not an excluded device

In addition to this certification at the time of application, sponsors have ongoing responsibilities once a device has been included in the ARTG.

Note

In order to meet your ongoing responsibilities and provide relevant information to the TGA within legislative time frames, you will need to maintain an ongoing relationship with the manufacturer of your product.

A sponsor's ongoing legislative requirements under the Therapeutic Goods Act 1989 are as follows:

Requirement Example(s) Legislative reference
Allow entry and inspections of premises
  • Allowing a person authorised by the TGA to enter and inspect any premises, including outside Australia, where the devices are manufactured or located.
  • While on the premises, allowing a person authorised by the TGA to inspect the premises and medical devices on the premises.
  • Allowing a person authorised by the TGA to take samples of medical devices from the premises.
Section 41FN(1)
Deliver samples upon request
  • Providing samples of the medical device to the TGA upon request.
Section 41FN(2)
Availability of information
  • Facilitating access to the technical documentation that demonstrates compliance with the Essential Principles.
  • Facilitating access to the evidence that appropriate conformity assessment procedures have been applied.
  • Providing this information to the TGA within specified timeframes when requested.
Section 41FN(3)
Advertising material
  • Ensuring any advertising material relating to the medical device complies with regulatory requirements.
Section 41FN(5)
Report details of certain incidents and performance issues to the TGA Section 41FN(3)(d)
Report any overseas regulatory actions to the TGA if the product involved is from the same batch or production run that was supplied in Australia
  • When an adverse event has occurred with a product in another country and the ensuing investigation by the manufacturer determines that a batch of the product should be recalled. If the batch is supplied in Australia the sponsor should notify the TGA of the overseas action to determine if the same action should occur in Australia.
Section 41FN
Report results of investigations undertaken by the manufacturer to the TGA
  • Relay the results to the TGA of an investigation into a returned sample associated with an adverse event report.
Section 41FN
Assist the TGA and the manufacturer in investigations if an incident occurs
  • Passing information to the TGA and the manufacturer during an investigation of an adverse event.
  • Assisting in the gathering of information and samples from the user.
Section 41FN
Take corrective action when necessary
  • Recalling medical devices.
  • Informing the public about medical devices that do not comply with requirements.
Section 41KA
Maintain distribution records for product supplied in or exported from Australia
  • Records of delivery to:
    • distribution warehouses
    • manufacturing sites
    • retails outlets

Section 41FO

Regulation 8.1(b)

Conditions imposed when medical devices are included in the ARTG
  • Provide annual reports for the first three years a Class III, AIMD, or Class IIb implantable device is available in Australia.
Section 41FO(2)

Version history
Version Description of change Author Effective date
V1.0 Original publication Medical Devices Branch October 2019