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Substantial changes affecting a TGA conformity assessment certificate and Transfers of certificates
Guidelines for notifying the TGA
The purpose of this guidance is to help manufacturers understand how the TGA interprets regulations, and thus indicate how a manufacturer can comply.
This is a guide only, and manufacturers and sponsors are encouraged to familiarise themselves with the legislative and regulatory requirements in Australia. If necessary, seek professional advice as it is the responsibility of each manufacturer or sponsor to understand and comply with these requirements.
This document will evolve over time and updates and clarifications will be included as required. Feedback on the guidance is always welcome.
This guidance is for manufacturers that have been issued conformity assessment certification by the Therapeutic Goods Administration (TGA) and are planning to make a change. This guidance also includes events that trigger a transfer of a conformity assessment certificate, and its associated responsibilities, to a new entity.
This guidance is not about urgent changes that require recall action.
These types of changes should begin with a notification to the TGA under the Uniform Recall Procedure for Therapeutic Goods.
If a manufacturer has been issued with a conformity assessment certificate by the TGA, both the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations) require manufacturers to notify the TGA about any plans for 'substantial changes', as these need to be assessed by the TGA before they are introduced.
This guidance has been prepared to assist manufacturers in deciding what is considered to be a 'substantial change' that would require notification to the TGA under the conformity assessment procedures.
For any change, whether substantial or not, manufacturers are expected to:
- have written procedures as part of their Quality Management System (QMS) to cater for change management, and to guide their related decision making, and
- consider the impact of changes on regulatory requirements and risk management, and
- document the details and analysis of changes so that the records will be available if requested by the TGA.
This guidance is only applicable to TGA-issued conformity assessment certificates.
If sponsors rely on conformity assessment certification issued by one of the European Notified Bodies (NBs) to support their ARTG entries, it is expected that substantial changes should be reported to those NBs for assessment.
The NBs will have their own procedures for assessing change, and re-issuing certificates if necessary. See Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System.
If the changes result in the reissue of a NB QMS certificate (or a new NB QMS Certificate) the sponsor should notify the TGA about this event via an application for variation to manufacturer's evidence.
If the changes assessed by the NB affect the information entered on the ARTG in relation to the device, e.g. changes to the intended purpose, changes to the functional description, changes to variants, etc., the TGA should also be notified through the ARTG variation process.