Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:3_4:p1
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 3 cl 4 (pt 1/3)
Character Range: 4353–7175

4  Definitions
Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:
(a) conformity assessment certificate;
(b) conformity assessment document;
(c) conformity assessment procedures;
(d) included in the Register;
(e) kind, in relation to a medical device;
(f) medical device;
(g) system or procedure pack.
  In this instrument:
Act means the Therapeutic Goods Act 1989.
application means an application to the Secretary for a kind of medical device to be included in the Register under section 41FC of the Act.
Canadian medical devices regulations means the Medical Devices Regulations (SOR/98-282) made under the Food and Drugs Act of Canada, as in force immediately before the commencement of this instrument.
certified translation means a translation that contains a statement, dated and signed by a person, to the effect that the translation is a true and complete translation of the accompanying document.
Class 1 IVD medical device has the same meaning as in the Regulations.
Class 2 IVD medical device has the same meaning as in the Regulations.
Class 3 IVD medical device has the same meaning as in the Regulations.
Class 4 IVD medical device has the same meaning as in the Regulations.
Class 4 in-house IVD medical device has the same meaning as in the Regulations.
Class I medical device has the same meaning as in the Regulations.
Class IIa medical device has the same meaning as in the Regulations.
Class IIb medical device has the same meaning as in the Regulations.
Class III medical device has the same meaning as in the Regulations.
clinical evaluation report means a report prepared by a manufacturer detailing the assessment and analysis of clinical data to verify the safety and performance of a medical device when used as intended by the manufacturer.
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 immediately before 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 immediately before the commencement of this instrument.
Directive 98/79/EC means Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, as in force immediately before the commencement of this instrument.
EU IVD regulation means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices, as in force on 1 December 2024.
EU medical devices regulation means Regulation (EU) 2017/745 of the European