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Warehouse Compliance

Compliance Management Requirement for regulatory purposes

ISO 13485:2003 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Objective of ISO 13485:2003

To facilitate harmonised medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001:2008 that are not appropriate as regulatory requirements. All requirements of ISO 13485:2003 are specific to organisations providing medical devices, regardless of the type or size of the organisation.

TGA accepts the following certificates and licenses as conformity assessment evidence

ISO 13485 Medical devices - Quality management system - Requirements for regulatory purposes certificate issued by:

  • a certification body that is also a Notified Body designated under the IVDD 98/79/EC
  • a CMDCAS (Canadian Medical Devices Conformity Assessment System) recognised Registrar
  • a certification body that is accredited by a signatory member of the International Accreditation Forum (IAF) Multilateral
  • Recognition Arrangement (MRA) to undertake certification to ISO 13485

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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Warehouse ISO13485

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