The TGA holds a repository of quality management system (QMS)-related conformity assessment documents, referred to as manufacturer evidence. A manufacturer evidence application must be submitted and accepted by the TGA before you can commence an application for any medical device. This manufacturer evidence is then linked to your ARTG entry.
At all times, while the inclusion of the device in the ARTG has effect, you, as a sponsor, must have available sufficient information to substantiate that the conformity assessment procedures have been applied to the kind of medical device in the ARTG, and ensure compliance with all conditions stated in section 41FN of the Act, and if applicable, any additional product specific conditions imposed when the device is included in the ARTG.
There are criminal and civil penalty sanctions if a sponsor fails to notify the TGA within 60 days of becoming aware that a conformity assessment document (other than a conformity assessment certificate issued by the TGA) has been restricted, suspended, revoked or is no longer in effect. You can notify the TGA of these occurrences using the Lapses in Conformity Assessment Notification Form.
For further information on Manufacturer Evidence, please see Manufacturer evidence for medical devices and IVD medical devices.
Types of conformity assessment
Conformity assessment documentation required to support inclusion of medical devices in the ARTG is prescribed in section 41FDB of the Act (preliminary assessment). The TGA guidance on these requirements is provided at Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs), at Table 2. This includes details on documentation required, depending on the risk classification of the device and the source of that documentation, for:
- QMS: the conformity assessment documentation relating to a manufacturer’s quality management system (QMS) issued by other Regulators, that the TGA will accept as manufacturer evidence to support inclusion of medical devices in the ARTG, detailed in the centre column headed “Manufacturer Evidence (QMS Certificate)”.
- Product assessment: conformity assessment documentation relating to product assessment where required, detailed in the right column headed “Documentation to be provided with application (Evidence of product assessment)”.
Updating manufacturer evidence
There are certain situations where sponsors will need to update or submit new manufacturer evidence, including if:
- You intend to submit a new application for inclusion in the ARTG with a new conformity assessment document
- You intend to submit an application to change an existing ARTG entry (a Device Change Request or a variation) and the conformity assessment document on file is outdated or inappropriate
- There are changes to the manufacturer name or address (where the manufacturer remains as the same legal entity, and the QMS remains the same, with conformity assessment document(s) available as evidence)
- When the TGA asks you to provide current manufacturer evidence to support existing ARTG entries