Medical device registration in Australia

Medical device registration in Australiaiso13484-2016

PharmOut offers consulting services for companies wishing to register medical devices with Australian TGA, for sale within Australia.

Our regulatory affairs consultants can advise on:

  • CE Marking
  • Medical Device product classification
  • Preparation of technical files
  • Risk assessments
  • Quality audits

We can provide advice on product development, preclinical and clinical research, regulatory affairs and quality assurance.

R&D programs for novel products

PharmOut can assist with planning R&D programmes for novel products; designing suitable studies to meet regulatory requirements and achieving timely approvals in target countries.

Our auditors can undertake cGMP, QSR, ISO 9001:2015, ISO 13485:2016 audits of companies, their suppliers and subcontractors, ensuring that appropriate standards of quality are met.

CE Marking of medical devices

Medical device registration in the European Union is now harmonised with four directives in force:

  • Medical Devices Directive
  • Active Implantable Medical Devices Directive
  • In Vitro Diagnostic Medical Devices Directive
  • Electromagnetic Compatibility Directive

Products bearing the CE mark can be freely marketed in all member states.

CE marking is an important milestone in getting your product ready to market. The critical first step is to work out which category your product falls into – this allows you to determine which legislation applies, and what the best route to market will be.

Our team can advise on regulatory, scientific and quality matters, including ISO 13485:2016, FDA QSR 820 and related standards.

We can support many types of medical devices: from active and non-active devices, including sterile and electromedical products, to in vitro diagnostics as well as drug-device combinations and borderline products.

More information

If you would like a quote or would need to ask questions, please contact us.