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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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4. Notification of substantial changes and transfers

For notification of a substantial change

Substantial changes must be notified and assessed by the TGA prior to supplying any products (kinds of devices) affected by those changes.

Notification of a substantial change is done via the TGA Business Services (TBS) portal using the standard conformity assessment application form. For guidance on how to do this, please go to: Application for conformity assessment certificates.

Note

  • On the first page of the TBS application form, ensure you select the option for change to an existing certificate.
  • In the Applicant's reference field, ensure you include: Substantial change to conformity assessment certificate.

What happens after you submit a notification

Following the receipt of an application for a substantial change, the TGA will contact the applicant (the manufacturer or their representative) if additional information is required to assess the change.

Manufacturers should allow adequate lead time for the TGA to consider and complete the assessment of the proposed changes before they occur. The assessment may require an on-site inspection which will be incorporated into the TGA's inspection schedule.

For notification of a certificate transfer

Notification of a conformity assessment certificate transfer is done via the TGA Business Services (TBS) portal using the standard conformity assessment application form. For guidance on how to do this, please go to: Application for conformity assessment certificates.

MD Regulation 4.10 states that if a person is required to notify the TGA of an event that results in transfer of conformity assessment certificates, the person must also provide us with sufficient documentary evidence of the relevant event (e.g. evidence of amalgamation of a business, evidence of the bankruptcy of a manufacturer, etc.).

Transfers must be notified to the TGA not later than 3 months after the change has taken place.

Note

  • On the first page of the TBS application form, ensure you select the option for change to an existing certificate.
  • In the Applicant's reference field, ensure you include: Transfer of conformity assessment certificate.
  • Please complete and include the Transfer of conformity assessment certificates form as part of your supporting evidence.

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