Manufacturing medical devices: where to start

15 July 2016

There are different regulatory requirements and processes that apply to medical device manufacturing activities.

Manufacturing medical devices in Australia for the Australian market

Australian Manufacturers of medical devices containing medicines or tissues of animal, biological or microbial origin, or Class 4 IVDs are required to hold a TGA Conformity Assessment Certificate before applying for inclusion onto the Australian Register of Therapeutic Goods (ARTG).

Refer to the Australian Regulatory Guidelines for Medical Devices (ARGMD) on how to apply for a TGA Conformity Assessment Certificate.

For Australian Manufacturers of Class I medical devices not supplied sterile or do not having a measuring function refer to the Australian Regulatory Guidelines for Medical Devices (ARGMD).

Manufacturing medical devices in Australia for export to overseas markets

Manufacturers wishing to apply for an export only medical device, need to have the device included on the Australian Register of Therapeutic Goods (ARTG) as a Class I medical device.

If a medical device is for export only and the manufacturer does not already have the device included on the ARTG, refer to How to make an application through DEAL.

Manufacturers wishing to supply their devices in Europe may obtain a CE Certificate from the TGA, through the MRA process. Refer to Australian Regulatory Guidelines for Medical Devices (ARGMD) for more information.

If your product is already on the ARTG and a manufacturer wishes to export to overseas markets, refer to importing/exporting for commercial purposes.

Manufacturing medical devices overseas for import into the Australian market

The following medical device manufacturers are required to obtain a TGA Conformity Assessment Certificate before the medical device can be included on the ARTG, and therefore be supplied into the Australian market:

  • Any manufacturer who manufactures medical devices containing materials derived of animal, microbial or recombinant origin.
  • Any manufacturer who manufactures medical devices containing medicinal substances (substances that if used separately would be considered medicines).
  • Any manufacturer who manufactures medical devices containing derivatives of human blood or plasma.

Refer to Australian Regulatory Guidelines for Medical Devices (ARGMD) on how to apply for a TGA Conformity Assessment Certificate.

Overseas manufacturers not manufacturing medical devices described above, and who hold current EC certification issued by an EU Notified Body under the EU Medical Devices Directive 93/42/EEC (MDD) or the EU Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) are allowed, under certain conditions, to use EC certificates to support an application for inclusion onto the ARTG. A copy of the required certification must be submitted to the TGA prior to the lodgement of the device application for inclusion to the ARTG.

Refer to 'Fact sheet 17 - Manufacturers' evidence for medical devices' on how to submit the correct certification documentation prior to lodging an application for inclusion onto the ARTG.

Overseas manufacturers with EC certification, as described above, may be selected for an application audit prior to inclusion onto the ARTG. Refer to the Australian Regulatory Guidelines for Medical Devices (ARGMD) for the requirements for applications selected for a pre-market audit.

An overseas manufacturers who is not EC certified by an EU Notified Body, should apply for a TGA Conformity Assessment Certificate. Refer to Australian Regulatory Guidelines for Medical Devices (ARGMD) on how to apply for a TGA Conformity Assessment Certificate.

There are medical devices where the classification in Australia is different to the European classification therefore the EC certification may not be appropriate to the Australian classification requirements. In these circumstances a TGA Conformity Assessment Certificate may be required. Alternatively, for eligible devices, the manufacturer may apply to a designated EU Notified Body for a certificate of conformity under the Australian-European Community (EC) Mutual Recognition Agreement (MRA).

Refer to