Grouping WAND Notifications by Kind under Regulation 5(3)

Regulatory information verified as of 29 October 2026

1. Key takeaways

Reg 5(3) of SR 2003/325 provides that where a Sponsor (New Zealand sponsor) is the Sponsor of 2 or more devices, information need only be entered in respect of each kind of device for which that Sponsor is the Sponsor, instead of device by device, provided those devices meet four conditions simultaneously — they are manufactured by the same manufacturer, have the same GMDNS code, have the same risk classification, and are Class I, Class IIa or Class IIb devices.

Reg 5(5) gives the test for the same kind: “those devices are—(a) substantially similar to one another; and (b) designed to be used in the same way and for the same purpose.” That is, substantially similar, and designed to be used in the same way and for the same purpose. The two limbs are cumulative; neither may be missing.

This is the only statutory cost-saving tool in the New Zealand notification stage: one entry covers several models, and the entry workload and the number of records to maintain fall together. But what grouping reduces is the entry duty, not product responsibility — Class III and AIMD are excluded by reg 5(3)(d) and must be entered item by item, with a unique product identifier recorded under reg 5(2).

Medsafe’s Sponsor duties statement separately lists three ongoing responsibilities unrelated to grouping: completing the WAND notification within 30 working days of becoming a Sponsor, keeping distribution records so all affected users can be contacted in a recall or corrective action, and informing Medsafe immediately of any recall or corrective action affecting supplied devices. Grouped entry does not change the granularity of these three.

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 legal effect of grouping is a reduction in entry work, not an exemption for products.

Reg 5(3) sits inside reg 5, and what it reduces is the duty to enter information into the database. The WAND record becomes coarser, but the safety evidence duty under s 38 of the Medicines Act 1981, the recall and corrective action duties, and the labelling and advertising duties are all borne per device and are not lightened by grouped entry. Reading grouped notification as one entry, the whole group is excused is the most common misreading of this provision.

Insight 2: the four conditions are parallel thresholds, not weighted indicators.

(a) the same manufacturer, (b) the same GMDNS code, (c) the same risk classification and (d) being Class I, IIa or IIb must all hold at once. Item (b) is especially critical: the GMDN is provided by the manufacturer as a 5-digit numeric code; scattered code selections within a product family forfeit grouping eligibility. Item (d) excludes the highest 2 classes: Class III and AIMD products can only be entered item by item however similar they are. IVDs likewise are not on this path — they use the IVD classification code and are not Class I, Class IIa or Class IIb, so item (d) fails (practical estimate).

Insight 3: the twin requirements of substantially similar plus the same way and the same purpose.

Models that differ only in size, colour or packaging specification while their functions and uses are the same will usually satisfy the twin requirements; but where models with different uses are mixed under one GMDN code — for example therapeutic versus diagnostic, or single-use versus reusable — limb (b) fails and they cannot be merged into the same kind (practical estimate). The determination should rest on intended purpose and method of use, not on appearance or model naming.

Insight 4: the greatest risk of grouping lies post-market.

After grouped entry, the WAND record stays at the granularity of the kind, while recalls and corrective actions must be precise to the specific model. Under the Medsafe page, the Sponsor has the duty to keep distribution records so that all affected users can be contacted in a recall or corrective action, and that duty requires distribution records to keep model, batch and flow information independently of the WAND record. If the WAND record is used as the product master data, grouping directly undermines the executability of a recall (practical estimate).

Insight 5: the correction duty of a grouped set is triggered as a whole.

Reg 8 provides that where information in a database record is no longer accurate or complete, the Sponsor must notify the correction within 10 working days, and the provision expressly refers to a medical device or kind of medical device. If any one device in a grouped set undergoes a manufacturer name change, a lapse of certification or any other inaccuracy, the whole grouped record is inaccurate and must be corrected as a group. Grouping reduces the number of records to maintain day to day; it does not change the sensitivity of the correction trigger.

4. Practical recommendations

• GRZAN recommends the grouping design before entry: build groups on the key manufacturer + GMDN 5-digit code + risk classification, settle group legality first and then the model list within the group, avoiding repeated splitting after entry.
• GRZAN requires a model list for each grouped set together with a written justification of substantially similar and designed to be used in the same way and for the same purpose; the justification must be confirmed by the manufacturer and serves as supporting material for the reg 7 declaration.
• Build distribution records separately by model and batch, and do not share the same table with the WAND grouped record; recall drills must reach model granularity (practical estimate).
• Manage Class III and AIMD devices in separate tables, make clear that the grouping route does not apply, and start the unique product identifier request at the same time.
• Have the manufacturer settle GMDN code selection uniformly before entry, avoiding scattered codes within a family that forfeit grouping eligibility.
• Write the inaccuracy of any one device in the group into the reg 8 correction trigger list, counted in 10 working days.

5. Verification checklist

• □ Grouping design has been completed on the key of manufacturer + GMDN 5-digit code + risk classification.
• □ All devices in the group are Class I, IIa or IIb, with no Class III or AIMD device mixed in.
• □ A written justification of substantially similar and designed to be used in the same way and for the same purpose has been produced and confirmed by the manufacturer.
• □ The model list of the group has been archived and kept together with the reg 7 declaration.
• □ Distribution records have been built independently by model and batch, and are not shared with the WAND grouped record.
• □ Recall drills have verified traceability down to model granularity.
• □ GMDN code selection has been settled uniformly by the manufacturer, with no scattering within the family.
• □ The inaccuracy of any one device in the group has been brought into the 10 working day correction trigger of reg 8.

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