Australian Regulatory Guidelines for Medical Devices (ARGMD) - Australian Government

Description

You may be required to comply with these guidelines if you intend to:

  • manufacture medical devices in Australia for the Australian market
  • manufacture medical devices in Australia for export to overseas markets
  • manufacture medical devices overseas for import into the Australian market.

The guidelines provide details about the classes of medical devices, safety, risks, performance and the clinical evidence needed to support the application for the inclusion of a medical device on the Australian Register of Therapeutic Goods.

Service type

Code of Practice

A code of practice is a set of rules which details how people in a certain industry should behave. A code of practice can be defined as a result of legislation or by industry regulators and bodies.

Eligibility requirements

Please consult the Contact Officer for more information and to ascertain the level of compliance that may be required.

Other resources

Task Business Structure Resources
Comply All Australian Regulatory Guidelines for Medical Devices (ARGMD) - Please consult the Contact Officer for information on this document.

Act(s) name

Therapeutic Goods Act 1989 Australian Government

Regulation(s) name

Therapeutic Goods Regulations 1990 Australian Government

Administering agency

Department of Health and Aged Care

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.