Compliance

We are licensed and/or registered and regulated by;

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Australian Government – Department of Health / Therapeutic Goods Administration

MetaGene is an ARTG IVD Registered Company and has been licensed to supply class 1, 2 and 3 IVD products to the Australian markets since 2014.

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Australian Government – Department of Agriculture and Water Resources

Licenced to import and supply purified or refined laboratory reagents, antibodies, antigens, human diagnostic tests, human diagnostic kits, human fluids and tissues, genetic material, cell lines and/or supernatant fluid.

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Electrical Regulatory Authorities Council Australia

  • Australian Communications and Media Authority
  • Global Compliance for Instruments that are shielded for Electromagnetic Radiation
  • Global Compliance for Instrumentation that meet legislated electrical safety standards
ERAC_RCM

The selected clinical manufacturers that MetaGene represents comply with:

MetaGene professional oversight is provided by our Board, Shand Taylor Lawyers and Pitcher Partners Accounting.

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