Document ID: chunk:federal_register_of_legislation:F2022C00960:reg:4
Version: federal_register_of_legislation:F2022C00960
Segment Type: reg
Provision Reference: reg 4
Character Range: 2304–4298

4  Definitions
            Note:  A number of expressions used in this instrument are defined in the Act, including the following:
              (a)     overseas regulator; and
              (b)     medical device.
In this instrument:
         Act means Therapeutic Goods Act 1989.
         active implantable medical device has the same meaning as in the Regulations.
         IAF accredited conformity assessment body means a body that is accredited to undertake certification for compliance with ISO 13485 by an accreditation body member that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum, Inc., otherwise known as the IAF MLA.
         in vitro diagnostic medical device has the same meaning as in the Regulations.
         ISO 13485 means International Standard ISO 13485:2016 Medical devicesQuality management systemsRequirements for regulatory purposes, issued by the International Organization for Standardization in March 2016, as in force or existing immediately before the commencement of this instrument.

         Note: ISO 13485 is published at: https://www.iso.org.
         notified body means a body that has been designated by a member state of the European Union, and notified to the European Commission, to assess the conformity of medical devices, including in vitro diagnostic medical devices and active implantable medical devices.

         recognised auditing organisation means an organisation authorised to perform audits under the Medical Device Single Audit Program by the Regulatory Authority Council, in relation to that program, comprising the Australian Therapeutic Goods Administration, the United States Food and Drug Administration, the Brazilian Agência Nacional de Vigilância Sanitária, Health Canada, and Japan's Ministry of Health, Labour and Welfare and the Japanese Pharmaceuticals and Medical Devices Agency.
         Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.