Document ID: chunk:federal_register_of_legislation:F2022L01534:clause:2_4:p1
Version: federal_register_of_legislation:F2022L01534
Segment Type: clause
Provision Reference: sch 2 cl 4 (pt 1/2)
Character Range: 1749–4722

4  Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) device number;
(b) included in the Register;
(c) kind, in relation to a medical device;
(d) medical device;
(e) overseas regulator conformity assessment document;
(f) Secretary;
(g) sponsor.
  In this instrument:
Act means the Therapeutic Goods Act 1989.
Council Directive 90/385/EEC means Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) of the Council of the European Communities, as in force or existing at the commencement of this instrument.
Council Directive 93/42/EEC means Council Directive 93/42/EEC of 14 June 1993 concerning medical devices of the Council of the European Communities, as in force or existing at the commencement of this instrument.
EU MDD certificate means an overseas regulator conformity assessment document that is issued by a notified body under Council Directive 93/42/EEC or Council Directive 90/385/EEC.
EU MDR certificate means an overseas regulator conformity assessment document that is issued by a notified body under the EU medical devices regulation.
EU medical devices regulation means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, as in force or existing at the commencement of this instrument.
GMDN Agency means the not-for-profit organisation, registered in the United Kingdom, responsible for the Global Medical Device Nomenclature system.
GMDN code, or Global Medical Device Nomenclature code, means the 5-digit numeric code assigned to all medical devices under the Global Medical Device Nomenclature system maintained by the GMDN Agency.
GS1 means the not-for-profit standards organisation known as GS1 that has its headquarters in Belgium.
GTIN, or Global Trade Item Number, means the GS1 identification key used to identify trade items.
Note: A GTIN comprises a GS1 company prefix, an item reference and a check digit.
instructions for use has the same meaning as in the Medical Devices Regulations.
intended purpose has the same meaning as in the Medical Devices Regulations.
Medical Devices Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
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.
online notification form means the online form Form: Sponsor notification for medical devices transitioning from the EU MDD to the EU MDR, which relates to the provision of information about a relevant kind of medical device and its transition, accessed via the TGA – Citizen Space website at https://consultations.tga.gov.au/tga/ef19f496/, as in force or existing at the commencement of