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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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3. Transfers of conformity assessment certificates

Transfers of a conformity assessment certificate to a new person or body corporate as a result of certain events are required to be notified to the TGA within 3 months following the transfer.

Note

You still need to notify us of any substantial changes (other than a name change) made in relation to a certificate transfer.

Ensure you notify us (in accordance with this guideline) prior to the substantial change(s) being implemented to allow time for the TGA to assess them.

Events that trigger a transfer

Division 4.3 of the MD Regulations applies to a manufacturer of a medical device in respect of whom a conformity assessment certificate is issued, and includes provisions about when a conformity assessment certificate is taken to be transferred to a new person or body corporate.

The MD Regulations state that such transfers occur where the manufacturer:

The manufacturer dies, becomes bankrupt, or is wound up

Regulation 4.6 of the MD Regulations provides that in this case:

  • the personal legal representative, trustee in bankruptcy or liquidator, as the case may be, is taken to be the person in respect of whom the certificate is issued (i.e. the new holder); and
  • the new holder must notify us of that event within 3 months of it occurring; and
  • provide us with sufficient documentary evidence of the relevant event (MD Regulation 4.10).

Disposal of business or amalgamation with another manufacturer

Regulation 4.7 of the MD Regulations provides that where the name of the manufacturer changes because either:

  • the manufacturer agrees to dispose of a business concerned with the manufacture of the medical device and it is agreed that the disposal is to include the transfer of the relevant conformity assessment certificate; or
  • the manufacturer, being a body corporate, amalgamates with another body corporate under a different name;

then

  • the person to whom the business is disposed of, or body corporate with whom the manufacturer amalgamates is taken to be the person in respect of whom the certificate is issued (i.e. the new holder); and
  • the new holder must apply for the name of the manufacturer to be changed on the conformity assessment certificate within 3 months of it occurring; and
  • provide us with sufficient documentary evidence of the relevant event (MD Regulation 4.10).

Manufacturer changes its name

Regulation 4.8 of the MD Regulations states that if the name of the manufacturer is changed, the manufacturer (as renamed) is taken to be the person in respect to whom the certificate was issued, and requires the manufacturer of the medical device to:

  • notify us within 3 months of a change of its name, and
  • provide us with sufficient documentary evidence of the relevant event (MD Regulation 4.10).

Examples of events that result in transfers that require notification to the TGA are provided in Appendix B.

When does the transfer actually take place?

The TGA does not make a determination as to when the transfer actually takes place. This is determined by the timing of the relevant event (e.g. the bankruptcy) as set out in Division 4.3 of the MD Regulations.

Once an event occurs, the new person or business is taken to be responsible for meeting the requirements related to the conformity assessment certificate, regardless of whether the TGA has:

  • been notified of the transfer or change, or
  • updated the relevant TGA conformity assessment certificate.

If a conformity assessment certificate is transferred because of the operation of Regulation 4.6, 4.7, or 4.8:

  • the legal and regulatory responsibilities transfer to the new holder of the certificate; and
  • the new holder can continue to produce the medical device(s) covered by the certificate while the certificate remains valid.

Manufacturers (and prospective new manufacturers) should get their own advice about:

  • the impact of MD Regulations 4.6, 4.7 and 4.8 on their status; and
  • their obligations under the Therapeutic Goods Act 1989 and its associated regulations when a conformity assessment certificate is transferred.

Note

If the TGA becomes aware that we have not been notified of an event that triggers a certificate transfer, we may suspend or revoke the conformity assessment certificate to which the event relates.

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