ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes - Australian Government


You may need to comply with this standard if you intend to supply medical devices and provide related services. If a therapeutic device is required to be listed or registered on the Australian Register of Therapeutic Goods, it must be manufactured according to the requirements of this standard.

The aim of this standard is to specify requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

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.

Act(s) name

Therapeutic Goods Act 1989 Australian Government

Regulation(s) name

Therapeutic Goods (Manufacturing Principles) Determination No. 1 2013 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.