Information for Medical Device Suppliers
In-Vitro Diagnostic (IVD) Devices
Pregnancy test kits are medicines in New Zealand, while most other IVDs are regulated as medical devices. IVDs are currently exempt from mandatory notification to WAND, but they must still comply with the requirements of the Medicines Act and its Regulations. IVDs may be voluntarily notified to the WAND database.
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.
Pregnancy Test Kits
Section 3 (1) (c) of the Medicines Act 1981 defines a pregnancy test kit as a medicine. Medicines that are supplied as medical devices are regarded as new, unapproved medicines. The Medicines Act 1981 has substantial penalties, including imprisonment, for suppliers of unapproved medicines.
It is important to ensure that products considered to be medicines in New Zealand are not supplied as though they are medical devices. Medicines (with a few, tightly controlled exemptions) must first undergo an approval process which is operated by Medsafe. Approval means that the Minister of Health has given consent to the sale, distribution and advertising of the medicine. A medicine that has not been approved is known as a 'new medicine' and cannot be freely sold, distributed or advertised.
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.
The exemption granted for IVDs was made by the Director-General of Health under Schedule 1(i) of the Medicines (Database of Medical Devices) Regulations 2003.
Suppliers of IVDs may use the risk classification of IVD when notifying devices to the WAND database. As at April 2011 there is no risk classification system for IVDs recognised by Medsafe. There are no charges associated with notification of devices to the WAND database.
IVD Exemption from the WAND database
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)
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.
Page last updated on 10 May 2011