I declare the following class of medical device to be an exempt class of medical device for the purposes of the Medicines (Database of Medical Devices) Regulations 2003:
Any diagnostic device that is commonly known as an
in vitro diagnostic device.
For the purposes of this notice, an in vitro diagnostic device means:
"any device which is-
(a) a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic devices for in vitro use; and
(b) intended by the manufacturer to be used in vitro for the examination of specimens (including blood and tissue donations) derived from the human body:
(i) solely or principally for the purpose of giving information about a physiological or pathological state or a congenital abnormality; or
(ii) to determine safety and compatibility with a potential recipient."
I make this declaration pursuant to paragraph (i) of
Schedule 1 of the Medicines (Database of Medical Devices) Regulations 2003.
This declaration comes into effect on 1 January 2004.
Dated at Wellington this 12th day of December 2003.
DR KAREN O. POUTASI, Director-General of Health.