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Manufacturer's ongoing responsibilities

11 October 2019

Manufacturers have ongoing legal obligations for medical devices that they manufacture that are supplied in Australia. These obligations are outlined in full in the therapeutic goods legislation including:

As part of the approval process to market a medical device in Australia a manufacturer must sign an Australian Declaration of Conformity. The Australian Declaration of Conformity states which conformity assessment procedures the manufacturer has chosen to use to demonstrate that their medical device meets the Essential Principles. The ongoing obligations for a manufacturer vary depending on which conformity assessment procedures they have used.

Full details of the ongoing obligations for each of the conformity assessment procedures are in Schedule 3 of the Therapeutic Goods Regulations (Medical Devices) 2002 (the Regulations). These surveillance activities are a critical part of the manufacturer's overall quality manufacturing system. The following table provides examples of how manufacturers can meet their ongoing responsibilities as set out in the legislation:

Requirement Example(s) Legislative reference
Manufacturer must maintain appropriate records
  • Technical documentation that demonstrates the conformity of their devices with the Essential Principles.
  • Evidence that an appropriate conformity assessment procedure has been applied.
  • The Australian Declaration of Conformity.
  • Details of any post-market activities undertaken after the device was supplied in Australia.
  • Details of any changes or variations to the device and/or quality management system—for more information, please see Varying entries in the ARTG - medical devices and IVDs.
  • Any notice, report, certificate or other document in relation to the quality management system issued to the manufacturer by the TGA.

For all devices that are not Class I non-sterile and non-measuring:

  • Details of the manufacturer's quality management system.
  • The design, production process and intended performance of the medical device
  • These records must be kept for a minimum of 5 years after the manufacture of the last medical device. On request from the TGA, the manufacturer must make the records available to the TGA
 Schedule 3 of the Regulations
Implement appropriate means to apply any necessary corrective action in relation to the design or production of a device

Unless covered by the exemption rules you must notify the TGA or the sponsor as soon as practicable after becoming aware of:

  • information relating to
    • any malfunction or deterioration in the characteristics or performance of the device
    • any inadequacy in the design, production, labelling or Instructions for Use of the device
    • any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device that might lead, or might have led, to the death of a patient or a user of the device in Australia, or to a serious deterioration or serious injury to his or her state of health.
  • information relating to any technical or medical reason for a malfunction or deterioration that has led the manufacturer to take steps to recover devices that have been distributed; and
  • systematically review information gained after the device was supplied in Australia.

For more information on reporting adverse events, please refer to Adverse Event Reporting.

 Schedule 3 of the Regulations

Note

Even though a certified quality system is not required for manufacturers of Class I (non-sterile or non-measuring) medical devices, the manufacturer is still required to have an ongoing surveillance system established, in accordance with clause 6.5 of Schedule 3 of the Therapeutic Goods Regulations (Medical Devices) 2002.

Manufacturers must also notify the TGA of substantial changes to the design, intended performance or quality management system of the device. For more information on changes, please see Varying entries in the ARTG - medical devices and IVDs.

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