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What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs

Version 1.0, November 2011

24 November 2011

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Suspension and revocation of certificates

If false statements are made in connection with an application for a TGA Conformity Assessment Certificate, fines up to a maximum of $6600 can be imposed (section 41EI).

Please note: Financial penalties are specified in the Act as penalty units. The value for each penalty unit is currently $110, in accordance with section 4AA of the Crimes Act 1914. This amount may change in the future.

Grounds also exist for revoking the certificate by written notice to the person who has been issued with the certificate under section 41ET of the Act if the TGA is satisfied that:

  • the conformity assessment procedures have not been applied to IVDs covered by the certificate
  • the manufacturer of the IVD covered by the certificate, refuses or fails to comply with a condition on the certificate
  • the manufacturer mentioned on the certificate no longer manufactures any of the kinds of IVDs covered by the certificate
  • the manufacturer mentioned on the certificate is not a fit and proper person
  • a person who is managing the affairs of the manufacturer mentioned on the certificate is not a fit and proper person
  • a person who has effective control over the manufacturer mentioned on the certificate is not a fit and proper person to have that control
  • a person fails to provide information or documents within 10 working days of a request from the TGA about:
    • a kind of IVD
    • a quality management system to which the certificate applies.

However, if it is likely that the grounds for revocation do exist, a TGA Conformity Assessment Certificate may be suspended prior to any revocation proceedings being put in place (section 41EM).

Suspension of a TGA Conformity Assessment Certificate leads to the suspension from the ARTG of the IVDs covered by the certificate. Supply of those devices in Australia is then suspended.

If a TGA Conformity Assessment Certificate is revoked, it will lead to the entry in the ARTG for the IVDs covered by that certificate being cancelled. Supply of those devices in Australia is then illegal.

Details of these procedures can be found in Divisions 3 and 4 of the Act, including the:

  • notices of proposed suspensions
  • duration of suspensions
  • revocation of suspensions
  • automatic revocation
  • immediate revocation
  • revocation
  • limiting revocation
  • publication of revocations
  • dates of effect of revocations.

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