ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes - Australian Government

Description

You may be required 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.

This aim of this standard is to define 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.

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.

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

Operating address: 136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address: PO Box 100
Woden
Australian Capital Territory 2606
Phone: 1800020653
Phone: 02 62328644
Fax: 02 62031605
Email: info@tga.gov.au