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Substantial changes affecting a TGA conformity assessment certificate and Transfers of certificates

Guidelines for notifying the TGA

29 June 2017

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2. What is not considered a 'substantial change'

The following categories of changes illustrate some of the types of changes which would not be considered by the TGA as substantial, and therefore would not require notification (there may be others):

  • changes to non-critical parts or suppliers that can be demonstrated to still meet the acceptance criteria established by the manufacturer
  • changes to manufacturing equipment or processes which are not likely to influence the level of risk to the user or patient
  • changes to the artwork, colour, font, or layout of the packaging and labelling of a medical device that does not alter compliance with Essential Principle 13.

Although notification is not required for the above changes, the MD Regulations require the manufacture to ensure they continue to meet the requirements of their QMS.

The manufacturer must maintain documentation of any changes as part of the QMS for traceability and recordkeeping purposes. Documentation of the changes must be provided for review by the TGA if requested, for example at an on-site inspection.

Examples of substantial changes that require notification to the TGA are provided in Appendix A.

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