Document ID: chunk:federal_register_of_legislation:F2025C00021:front:0:p11
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testing
     Dictionary
Endnotes
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history

Part 1—Preliminary

1.1  Name of Regulations
  These Regulations are the Therapeutic Goods (Medical Devices) Regulations 2002.

1.3  Definitions—the dictionary etc
 (1) The dictionary at the end of these Regulations defines certain words and expressions, and includes, for that purpose, references to certain words and expressions that are defined in the Act or elsewhere in these Regulations (signpost definitions).
Example: The signpost definition 'medical device—see section 41BD of the Act' means that the expression medical device is defined in section 41BD of the Therapeutic Goods Act 1989.
Note: The dictionary only includes a signpost definition for a word or expression that is defined elsewhere in these Regulations if the word or expression is used in more than one regulation.
 (2) The dictionary is part of these Regulations.
 (3) A definition in these Regulations applies to each use of the word or expression in these Regulations, unless the contrary intention appears.

1.4  Medical devices with a measuring function
 (1) For these Regulations, a medical device has a measuring function if the device is intended by the manufacturer to measure:
 (a) quantitatively a physiological or anatomical parameter; or
 (b) a quantity, or a qualifiable characteristic, of energy or substances delivered to or removed from the human body.
 (2) This regulation does not apply to an IVD medical device.

1.5  Refurbishment (Act s 3(1))
 (1) A refurbishment of a medical device is taken to have occurred if the medical device, or a part of the device, is substantially rebuilt from one or more used medical devices of that kind so as to create a medical device that is able to be used for the purpose originally intended by the manufacturer of the original device.
 (2) Without limiting subregulation (1), a refurbishment of a medical device may involve the following actions:
 (a) stripping the device into component parts or sub‑assemblies;
 (b) checking parts of the device for suitability for reuse;
 (c) replacing component parts or sub‑assemblies of the device that are not suitable for reuse;
 (d) assembling reclaimed or replacement component parts or sub‑assemblies of the device or another used device;
 (e) testing a reassembled device against the specifications of the original device or, if the manufacturer has revised those specifications, the revised specifications;
 (f) identifying an assembled device as a refurbished device.

1.6  Kinds of medical devices—other common characteristics (Act s 41BE(1)(e))
  For paragraph 41BE(1)(e) of the Act, in relation to any of the following medical devices, a characteristic is the unique product identifier of the device:
 (a) a Class 4 IVD medical device, other than an immunohaematology reagent IVD medical device that is a Class 4 IVD