GMDN Code Requirements for Medical Device Notification in New Zealand

Regulatory information verified as of 29 October 2026

1. Key takeaways

New Zealand is one of the few jurisdictions that writes its device nomenclature system directly into regulations. Regulation 5(1)(c) of SR 2003/325 expressly requires that, for every non-exempt device, the GMDN product description for that device be entered. This is the only nomenclature requirement in the New Zealand WAND (Web Assisted Notification of Devices) notification with a statutory source, standing alongside risk classification and party information; it cannot be omitted, and it cannot be replaced by a trade name, a model number or an internal company code.

The GRZAN regulatory team confirms three points after verification. First, the GMDN code is a 5-digit code; in the IVD case, the 5-digit code is provided by the manufacturer. Second, Medsafe does not recognise any IVD risk classification model; IVDs uniformly use the separate risk classification code IVD in WAND, a different field from the GMDN field that cannot substitute for it. Third, the GMDN code is determined on the manufacturer’s side, but signed responsibility for the entry’s accuracy and completeness rests with the Sponsor (New Zealand sponsor) under the declaration requirement of reg 7(c).

A wrong GMDN code is more than a naming problem, because it has knock-on consequences: one of the premises of grouped entry under reg 5(3) is the same GMDN code, so inconsistent codes defeat the grouping route outright; inaccurate information triggers the 10 working day correction duty under reg 8, which in turn touches the penalty in reg 14 (fine not exceeding NZ$500 on conviction).

Viewed the other way round, the GMDN is one of the few positive requirements in the New Zealand system. New Zealand has no pre-market approval, issues no registration certificates, and Medsafe performs no technical review; WAND is a mandatory post-arrival notification database, and Medsafe does not rule on classification, so investment in technical documentation is voluntary. The GMDN entry is the one element the law expressly requires — and requires to be GMDN. GRZAN accordingly recommends treating GMDN term selection as mandatory, not optional.

2. Legal basis

The table below lists the regulatory and official sources verified for this article and the provisions relied on.

3. Expert insights

Insight 1: the GMDN is a nomenclature field, not a classification field.

Reg 5(1) places (a) risk classification and (c) the GMDN product description side by side as two independent requirements. Risk classification answers how hazardous the device is; the GMDN answers what the device is. The common confusion in practice is to use GMDN terms to infer the classification, or the classification to infer the GMDN; there is no statutory correspondence between the two.

Insight 2: the source of the 5-digit code position.

Within the scope verified, the GMDN is applied in New Zealand as a 5-digit code; for IVDs, that code is provided by the manufacturer. A Sponsor should not compile or alter codes on its own. At entry, record both the code and the GMDN term name completely; the code without the term, or the term without the code, can leave the record incomplete.

Insight 3: code selection method — the same logical starting point as classification.

Reg 13(2) provides that a device must be classified according to its intended purpose. The starting point for GMDN code selection is likewise the intended purpose, not the product’s appearance, materials or model number. GRZAN recommends four steps: have the manufacturer fix the intended purpose and applicable patient population in writing; search the GMDN terms against that purpose; compare the term definition word by word against the product’s key features; and, once confirmed, record both the 5-digit code and the term name in the technical documentation.

Insight 4: the dual-field peculiarity for IVDs.

IVDs in New Zealand follow the route of an exemption notice plus a separate classification code: Medsafe does not recognise any IVD risk classification model, and a uniform risk classification code IVD is used in WAND notification. In an IVD record, therefore, the classification field takes IVD while the nomenclature field still takes the GMDN 5-digit code; the two fields differ in source and basis, and cannot overwrite each other.

Insight 5: a list of common errors.

First, using a trade name or model number instead of the GMDN. Second, using a collective term to cover a batch of products loosely, so that grouped entry no longer matches reality (practical estimate). Third, assigning several GMDN codes to one product across models. Fourth, reusing other nomenclature codes from the European Union system as GMDN (practical estimate). Fifth, a Sponsor failing to synchronise after the manufacturer changes a code, leaving the record inaccurate long term.

4. Practical recommendations

• GRZAN lists the GMDN as one of the manufacturer-issued documents in WAND notification projects, requiring the manufacturer to provide the 5-digit code, the term name and a printout of the term definition together; verbal codes are not accepted, since the reg 7(c) signing responsibility rests with the Sponsor, not the manufacturer.
• GRZAN recommends fixing a GMDN selection note in the technical documentation, stating the intended purpose, the search path, the near-miss terms that were excluded and the reasons for exclusion. This note can be used directly in later Medsafe queries, classification disputes and reg 8 corrections (practical estimate).
• One product corresponds to one GMDN; model differences should not be expressed through multiple codes. Product lines genuinely differing in use should be split by purpose and coded separately (practical estimate).
• Where grouped entry under reg 5(3) is intended, group by GMDN first and remove devices with different GMDN codes from the grouping scope, so that the grouped record does not conflict with the conditions of the provision.
• Set up code-change monitoring: after a code change, the Sponsor must complete the WAND correction within 10 working days (reg 8); GRZAN recommends writing the notice obligation into the manufacturer agreement.
• Before entry, re-check the term definition’s coverage, especially for devices with measuring functions, sterile supply or medicinal substances, which are usually stated explicitly there.
• Broad product lines should maintain a product–GMDN–risk classification cross-reference table under a designated owner, bringing code, class and manufacturer changes uniformly into the reg 8 trigger, so that records do not drift apart (practical estimate).

5. Verification checklist

• □ A GMDN 5-digit code and the corresponding term name have been determined for every device to be notified.
• □ The GMDN code has been provided by the manufacturer; the Sponsor has not compiled or altered codes on its own.
• □ Code selection has been completed by intended purpose rather than by model or appearance, and a printout of the term definition has been retained.
• □ IVD records have been confirmed to use the IVD code in the classification field, without confusion with the GMDN field.
• □ The same product has not been filed with multiple GMDN codes; product lines have been correctly split by substantive differences in use.
• □ Records intended for grouped entry have been verified as grouped under the same GMDN.
• □ GMDN code-change monitoring and a 10 working day correction trigger mechanism are in place.
• □ The entered content is consistent with the accurate and complete declaration requirement of reg 7(c).

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 prepares WAND-compliant evidence dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com