Commonwealth Numbered Regulations

THERAPEUTIC GOODS LEGISLATION AMENDMENT (2019 MEASURES NO. 1) REGULATIONS 2019 (F2019L01660) - SCHEDULE 4

Therapeutic Goods (Medical Devices) Regulations 2002

1  At the end of regulation 1.6

Add:

                   ; (d)  an IVD companion diagnostic.

2  Paragraphs 4.3F(e) and 4A.31(h)

Omit "or (c)", substitute ", (c) or (d)".

3  At the end of paragraph 5.3(1)(j)

Add:

                           ; (x)  an IVD companion diagnostic.

4  After paragraph 1.3(f) of Schedule 2A

Insert:

                    (fa)  use as an IVD companion diagnostic;

5  Clause 1.3 of Schedule 2A (note)

After "IVD medical device", insert "(except an IVD companion diagnostic)".

6  Dictionary

Insert:

"IVD companion diagnostic " means an IVD medical device:

                     (a)  that is intended by the manufacturer to be used for the examination of a specimen from the body of an individual:

                              (i)  to identify whether the individual would be likely to benefit from the use of a particular medicine or biological; or

                             (ii)  to identify whether the individual is likely to be at particular risk of a serious adverse reaction to the use of a particular medicine or biological; or

                            (iii)  to monitor the individual's response to the use of a particular medicine or biological; and

                     (b)  that is mentioned in product information for the medicine or biological as being essential for the safe and effective use of the medicine or biological; and

                     (c)  if the medicine or biological comprises blood, a blood component, cells, tissue or an organ, from a donor other than the individual--that is not intended by the manufacturer to be used for the examination of the specimen merely to determine whether the medicine or biological is compatible with the individual.