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Medical Devices
Web Assisted Notification of Devices (WAND)

Exemption for In-Vitro Diagnostic Devices

24 December 2003

Diagnostic devices for in-vitro use are exempt from the notification requirements under the Medicines (Database of Medical Devices) Regulations 2003.  A Gazette Notice to give effect to this was published on 18 December 2003, and is copied below.

Exemption Medical Devices (in vitro Diagnostic Devices) Notice (No. 1) 2003

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-

1. 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
2. intended by the manufacturer to be used in vitro for the examination of specimens (including blood and tissue donations) derived from the human body:
   1. solely or principally for the purpose of giving information about a physiological or pathological state or a congenital abnormality; or
   2. 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.