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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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Appendix B: Examples of certificate transfers

Examples below illustrate some events that would be considered to trigger the transfer of a conformity assessment certificate.

  • A manufacturer holds a TGA Conformity Assessment Certificate for the manufacture of several Class 4 IVD medical devices. The company also manufactures a range of lower class IVD medical devices. The manufacturer decides to separate the Class 4 IVDs from the rest of the business through sale of the lower class IVDs to another company. The Class 4 IVD manufacturer retains the same QMS but changes its name. In such a case, MD Regulation 4.8 would require the manufacturer to notify us about the change of name within 3 months.
  • A corporation has multiple divisions, some medical device and some pharmaceutical. Each division maintains its own QMS. The corporation decides to separate the pharmaceutical and medical device businesses into two separate entities. The pharmaceutical business is to retain the current business name and registration. The medical device businesses are to change name and register as new business entities. The medical device businesses hold TGA Conformity Assessment Certificates for the manufacture of the medical devices. The certificates are transferred to the new entity. In such a case, MD Regulation 4.7 would require the new business to apply to us for the name of the manufacturer to be changed on the conformity assessment certificate within 3 months.
  • A manufacturer holds a TGA Conformity Assessment Certificate and amalgamates with another corporation that manufactures medical devices that do not require a TGA Conformity Certificate for supply in Australia. The new entity (business) takes on a new name but retains all the current manufacturing sites of the two prior corporations. The TGA Conformity Assessment Certificate is transferred to the new entity, but the scope of the certificate does not increase to cover the devices at the second site. In such a case, MD Regulation 4.7 would require the new business to apply to us for the name of the manufacturer to be changed on the conformity assessment certificate within 3 months.
  • A manufacturer holds a TGA Conformity Assessment Certificate and declares bankruptcy. The Trustee in bankruptcy becomes the legal manufacturer of the medical devices. In such a case, MD Regulation 4.6 would require the trustee to inform us of the event within 3 months.

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