Revised: 10 July 2014
Medical Devices
In-Vitro Diagnostic (IVD) Devices
IVDs are currently exempt from mandatory notification to WAND, but they must still comply with the requirements of the Medicines Act 1981 and its Regulations. IVDs may be voluntarily notified to the WAND database.
Regulatory status
IVDs have a therapeutic purpose of diagnosing disease or ascertaining the existence, degree, or extent of a physiological condition and are considered as medical devices in the Medicines Act 1981. This requires IVDs to comply with the requirements for medical devices specified in the Medicines Act 1981 and its associated Regulations.
Section 38 of the Medicines Act 1981 grants the Director-General of Health the power to investigate any medical device, including IVDs that are believed to be unsafe.
Voluntary notification to the WAND database
IVDs are exempted from mandatory notification to the WAND database, but suppliers of IVDs may voluntarily notify their devices to the database.
As at July 2014 there is no risk classification system for IVDs recognised by Medsafe. All IVDs notified to WAND are to use the risk classification code of IVD.
IVDs being notified to the WAND database are not required to have information about material of animal origin, or the formulation of the IVD, entered into the database as IVDs do not come into direct contact with the patient.
There are no charges associated with notification of devices to the WAND database.
IVD exemption from the WAND database
The exemption granted for IVDs was made by the Director-General of Health under Schedule 1, paragraph (i) of the Medicines (Database of Medical Devices) Regulations 2003.
Diagnostic devices for in-vitro use are exempt from the mandatory notification requirements under the Medicines (Database of Medical Devices) Regulations 2003. A Gazette Notice giving effect to this was published on 24 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-
- 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
- intended by the manufacturer to be used in vitro for the
examination of specimens (including blood and tissue donations) derived
from the human body:
- solely or principally for the purpose of giving information about a physiological or pathological state or a congenital abnormality; or
- 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.
Conducting recalls and corrective actions
Safety related actions taken by manufacturers and suppliers of IVDs to address issues affecting products in the market are called recalls and/or corrective actions. These should be conducted in consultation with Medsafe according to the Ministry of Health Uniform Recall Procedure for Medicines and Medical Devices.
The exemption for IVD’s is specific to mandatory notification to the WAND database. IVDs are categorised as medical devices under the Medicines Act 1981 and suppliers of IVDs are expected to notify Medsafe of any safety issue or corrective action that may be required.
