Commonwealth Numbered Regulations

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THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 2002 No. 236 - REG 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 AIMD medical device, Class III medical device, Class IIb medical device or Class IIa medical device — the relevant preferred term; and

(b)
for any of the following:

(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 —
the relevant preferred term; and

(c)
for any other Class I medical device — the relevant template term.

(2)
In this regulation:

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).


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