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 or for export to overseas markets, or if you 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.

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

Service type

Code of Practice

A code of practice can be either a legal requirement or non-legal requirement. Legal codes of practice are defined as a result of legislation. Non-legal codes of practice are defined by industry regulators and bodies.

Act(s) name

Therapeutic Goods Act 1989 AG

Regulation(s) name

Therapeutic Goods Regulations 1990 AG

Administering agency

Department of Health

Therapeutic Goods Administration

Contact details

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

Information Officer

Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Phone: 02 6232 8644
Fax: 02 6203 1605
Email: info@tga.gov.au