IVD Exemption Notice 2003: Single Risk Classification and GMDN Codes

Regulatory information verified as of October 29, 2026.

1. Key takeaways

New Zealand treats in vitro diagnostic devices (IVDs) differently from most markets. The Director-General, Dr Karen O. Poutasi, made the Exemption Medical Devices (in vitro Diagnostic Devices) Notice (No. 1) 2003 in Wellington on 12 December 2003, declaring under paragraph (i) of Schedule 1 of the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325) that any diagnostic device commonly known as an IVD is an exempt medical device, with effect from 1 January 2004.

Medsafe recognises no IVD risk classification model and assigns all IVDs a single classification. Its official guidance says, in effect: the risk classification is selected from a drop-down list when notifying a device, and sponsors notifying an IVD to the WAND database should use the risk classification IVD. This corresponds to neither the A/B/C/D classes of the EU IVDR nor the IVD grading systems common elsewhere, and must not be transplanted. In addition, IVDs notified voluntarily to WAND do not require entry of animal-derived material information or product formulation.

The GMDN code remains mandatory. Medsafe states expressly that the GMDN system contains many IVD-specific codes, that the Sponsor (New Zealand sponsor) of an IVD should obtain the correct GMDN code from the manufacturer, and that both the 5-digit code and its descriptor must be obtained.

On the Gazette publication date of the notice, GRZAN must flag a caution: the two relevant pages of the Medsafe website contradict each other, so no single date can be confirmed. This article and external company documents therefore state only that the notice was signed in December 2003 by the Director-General Dr Karen O. Poutasi under paragraph (i) of Schedule 1 (signed on the 12th) and took effect on 1 January 2004, without a Gazette publication date. The signature and effective dates are clearly recorded in the notice itself and can be used directly.

2. Legal basis

Official sources: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-8MDExempt.asp ; https://www.legislation.govt.nz/regulation/public/2003/0325/latest/

3. Expert insights

Insight 1: the IVD definition in the notice has four elements. Element one, physical scope: reagents, reagent products, calibrators, control materials, kits, instruments, apparatus, equipment or systems, used alone or combined with other IVDs. Element two, context of use: intended by the manufacturer for the in vitro examination of specimens derived from the human body, including blood and tissue donations. Element three, one purpose limb: used solely or principally to provide information on physiological or pathological states or congenital abnormalities. Element four, the other limb: used to determine the safety and compatibility of a potential recipient. Together the four elements fix the outer boundary of what is commonly known as an IVD.

Insight 2: Medsafe’s own statements contain a contradiction the company must resolve itself. Medsafe states that the Director-General declared IVDs exempt from notification to WAND under Schedule 1(i) on 12 December 2003, yet also gives operational guidance that when notifying an IVD to WAND the Sponsor should use the risk classification IVD. The two statements point in different directions. GRZAN’s operating position is to treat IVDs as still notifiable, with the classification field set to IVD (a practical estimate — an experienced judgement from the official guidance, not an express statutory conclusion). This satisfies the stricter requirement under either statement and avoids the reg 14 offence for failure to notify.

Insight 3: the practical consequences of a single class. Because Medsafe recognises no IVD grading model, no A/B/C/D mapping is possible in New Zealand. Three consequences follow. First, the 22 risk classification rules of Schedule 2 do not apply to IVDs; the classification step collapses to entering IVD. Second, the reg 5(2) unique product identifier requirement for Class III and AIMD devices does not apply to devices classified IVD. Third, IVDs notified voluntarily require no entry of animal-derived material information or product formulation — unlike the extra declarations some markets demand for animal-origin devices, so no additional dossiers are needed.

Insight 4: exemption does not waive post-market duties. Like the other Schedule 1 exemptions, IVDs remain subject to the other requirements of the Medicines Act 1981 and its regulations, including the safety duty under s 38, the labelling and advertising requirements of the Medicines Regulations 1984 (SR 1984/143), and the duty to notify post-market actions. Medsafe requires recalls, product corrections, alerts, safety alerts and other safety actions on exempt devices to be notified to it.

4. Practical recommendations

• GRZAN recommends locking the classification position at project initiation for IVD programmes: enter IVD in the WAND risk classification field and perform no grade conversion. If the company internally retains EU IVDR grades, keep the two field sets side by side in the data sheet so the entry step is not mistakenly filled with a general class such as Class IIa.
• GRZAN requires the 5-digit GMDN code and its English descriptor to be managed as a pair. Medsafe expressly requires the Sponsor to obtain code and descriptor together from the manufacturer; a code without a descriptor creates ambiguity in verification and traceability, and can trigger the 10 working day correction duty under reg 8.
• The IVD exemption assessment must check Schedule 1 paragraph (e) and the 2003 notice together: (e) covers only IVDs intended for use in a particular laboratory, the notice covers all diagnostic devices commonly known as IVDs — both apply in combination.
• When citing the notice externally, state only that it was signed in December 2003 by the Director-General Dr Karen O. Poutasi under paragraph (i) of Schedule 1 and took effect on 1 January 2004. The two Medsafe pages contradict each other on that date, so no specific date should be fixed in company documents.
• Even when treated as exempt, complete the WAND notification and keep the record. This covers both of Medsafe’s statements and leaves a traceable baseline of data in case the rules later change (a practical estimate).

5. Verification checklist

• □ Product confirmed to meet the IVD definition in the notice (physical forms, in vitro examination of human specimens, one of the two purpose limbs)
• □ WAND risk classification field confirmed as IVD, with no IVD grading model applied
• □ GMDN 5-digit code and descriptor obtained from the manufacturer and stored as a pair
• □ Schedule 1 paragraph (e) and the 2003 exemption notice assessed together
• □ The reg 5(2) Class III / AIMD unique product identifier requirement confirmed as not applicable
• □ Voluntarily notified IVDs confirmed to need no animal-derived material information or product formulation
• □ External documents state only December 2003 signature (Director-General Dr Karen O. Poutasi, under Schedule 1 paragraph (i)) and 1 January 2004 effectiveness, with no Gazette publication date
• □ Known that Medsafe’s two pages contradict each other on the Gazette publication date, with the internal position unified
• □ IVDs confirmed still subject to the s 38 safety duty of the Medicines Act 1981 and the labelling and advertising requirements of the 1984 regulations
• □ Internal route established for notifying post-market actions on exempt devices (recalls, product corrections, alerts, safety alerts) to Medsafe
• □ Known that Medsafe’s website carries two wordings on the Gazette publication date, with the internal position unified

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the New Zealand market. Our team manages WAND entries and sponsor registration, prepares reference-market evidence, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com