ISO 13485 certificates issued by a recognised body
The TGA has determined that ISO 13485 certificates issued by recognised bodies may be accepted as Manufacturer's Evidence.
An ISO 13485 certificate covers the quality management system but does not include review of the product and does not provide assurance that the Australian legislative requirements (e.g. the Essential Principles) have been taken into consideration.
Therefore some applications to include IVDs in the ARTG that use ISO 13485 certification as Manufacturer's Evidence may be required, under the provisions of Regulation 5.3, to undergo additional pre-market review.
For Class 2 IVDs, ISO 13485 certificates are generally sufficient for entry of an IVD in the ARTG. Unless the device is selected for an application audit under any of the subparagraphs (1)(j)(i)-(vii) in Regulation 5.3, or for a non-mandatory application audit under section 41FH (1) (b), an application for a Class 2 IVD that uses an ISO 13485 certificate as Manufacturer's Evidence will not undergo additional pre-market review.
Under subparagraph (1)(j)(viii) in Regulation 5.3, Class 3 IVDs covered by an ISO 13485 certificate will be subject to a mandatory application audit once the sponsor lodges an application for inclusion in the ARTG. However if the sponsor provides evidence of a Class III or IV Medical Device Active Licence Listing (MDALL) issued by Health Canada under the Canadian Medical Devices Regulations for the Class 3 IVD (as an attachment to the device application form) the IVD will not normally be selected for an application audit under Regulation 5.3(l)(j)(viii).
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