Document ID: chunk:federal_register_of_legislation:F2025C00021:front:0:p12
Version: federal_register_of_legislation:F2025C00021
Segment Type: other
Provision Reference: 
Character Range: 33274–36143

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 medical device;
 (c) a Class III medical device;
 (d) an IVD companion diagnostic.

1.7  Device nomenclature system codes (Act s 41BE(3))
 (1) In accordance with the Global Medical Device Nomenclature System Code, as set out in ISO 15225:2000(E), the device nomenclature system code specified for a medical device is:
 (a) for a Class 4 IVD medical device—the relevant preferred term; and
 (b) for a Class 4 IVD medical device that is an immunohaematology reagent IVD medical device—the relevant Level 2 collective term; and
 (c) for a Class 3 IVD medical device—the relevant Level 3 collective term, or if no Level 3 collective term exists, the relevant Level 2 collective term; and
 (d) for a Class 2 IVD medical device—the relevant Level 2 collective term; and
 (e) for a Class 1 IVD medical device or an export only IVD medical device—the relevant Level 1 collective term; and
 (f) for a Class III medical device, Class IIb medical device or Class IIa medical device—the relevant preferred term; and
 (g) for any of the following—the relevant preferred term:
 (i) a Class I medical device that the manufacturer intends to be supplied in a sterile state;
 (ii) a Class I medical device that has a measuring function;
 (iii) a Class I medical device for which there is no relevant template term; and
 (h) for any other Class I medical device—the relevant template term.
 (2) In this regulation:
collective term means a term that:
 (a) is used for those medical devices that share common features; and
 (b) is identified in the Global Medical Device Nomenclature System Code; and
 (c) is included in the document Collective terms available as device nomenclature system codes for IVD medical devices for the purposes of section 41BE(3) of the Act, published by the Therapeutic Goods Administration, as updated from time to time.
Examples:
Examples of the use of a collective term include the following:
         (a) to illustrate the scope of certificates issued by conformity assessment bodies when assessing which groups, families or types of medical devices are covered within a manufacturer's quality system;
         (b) to identify the range of skills and general technological abilities for which a conformity assessment body has been approved and is so appointed by the relevant regulatory authority;
         (c) for the exchange of information between regulatory authorities when general information on individual manufacturers' capabilities is notified.
ISO 15225:2000(E) means International Standard ISO 15225:2000(E) (Nomenclature—Specification for a nomenclature system for medical devices for the purposes of regulatory