Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(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 data exchange).
"relevant preferred term" , for a medical device, means the preferred term for that device under ISO 15225:2000(E).
"relevant template term" , for a medical device, means the template term for that device under ISO 15225:2000(E).