Class I Subclasses in New Zealand: Basic, Measuring and Sterile Devices

Regulatory information verified as of 29 October 2026

1. Key takeaways

New Zealand has five risk classes: under regulation 11 of SR 2003/325, Class I is the lowest, Class IIa and Class IIb are progressively higher, and Class III and AIMD are the highest classes. Within Class I, the WAND (Web Assisted Notification of Devices) notification system further distinguishes the basic, measuring and sterile subclasses. The 22 Schedule 2 rules determine the class; the three subclasses are a second-layer selection made after the class has been determined.

After verifying the official text, the GRZAN regulatory team points to a fact that is often overlooked: the body of SR 2003/325 (including reg 11 and Schedule 2) does not contain any stand-alone definition provisions for basic, measuring or sterile; Schedule 2 simply lands devices in Class I through two fallbacks, rule 2 (non-invasive devices are Class I by default) and rule 10 (active devices are Class I by default). The three subclasses come from the GHTF classification framework adopted in the Medsafe risk classification guidance and the WAND entry system, and are an operational-level convention (practical estimate).

Return to the origin of the system: New Zealand has no pre-market approval for medical devices, issues no registration certificates, and Medsafe performs no technical review; WAND is a mandatory post-arrival notification database, not a pre-market access gate. The entire function of classes and subclasses is to fill in the WAND record correctly.

For the Sponsor (New Zealand sponsor), a wrong subclass means not a fine but a record that no longer matches the product, creating exposure under the reg 7(c) accurate-and-complete declaration and possibly triggering the 10 working day correction duty under reg 8.

The subclasses merit their own article because Class I has the largest notification volume in New Zealand. Most basic dressings, ordinary surgical instruments, wheelchairs, eyeglass frames and conventional non-sterile consumables fall here; the class itself is rarely disputed, and the disputes concentrate on the choice of subclass (practical estimate).

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: determine the class first, then select the subclass.

Rules 2 and 10 of Schedule 2 share the same structure — Class I by default unless another rule of this Schedule assigns a higher class. This means Class I is the product of exclusion, not of active selection. Only after confirming that the device is not hit by any higher-class rule does subclass selection begin. Reversing the order, selecting a subclass first and then fitting the rules, is the most common determination error in practice (practical estimate).

Insight 2: the determination criteria for the three subclasses.

• Basic: the device has no measuring function and is not supplied sterile. This is the default state of Class I; anything that does not fall into the other two subclasses is basic.
• Measuring: the device has a measuring function whose measurement accuracy has a substantive bearing on clinical judgement or patient management. The key to the determination is whether measurement is one of the core intended purposes of the device, not whether a scale happens to be printed on it.
• Sterile: the device is supplied sterile, or its intended use requires it to be sterile at the time of use. The key to the determination is the manufacturer’s supply state and intended purpose, not whether the end user sterilises it themselves.

These determination criteria derive from the prevailing operational conventions under the Medsafe classification framework; SR 2003/325 does not define each of them (practical estimate). Companies should take the manufacturer’s written confirmation of the supply state and intended purpose as the basis of determination.

Insight 3: how to handle a device that meets several subclasses at once.

Schedule 2 and reg 13 contain no dedicated provision for subclass conflicts. Reg 13(7) provides that where several rules apply, the highest class is taken; GRZAN considers that this take-the-highest logic can be applied by analogy to subclass conflicts, so that a measuring device supplied sterile is filed under the stricter subclass (practical estimate). This treatment involves no change of class and affects only the precision of the WAND record.

Insight 4: three knock-on effects of subclass selection.

First, the subclass does not change the class and therefore does not trigger the UPI requirement of reg 5(2) — the UPI applies only to Class III and AIMD. Second, Class I falls within the scope of grouped entry under reg 5(3), provided the manufacturer, the GMDN code and the risk classification are the same. Third, an inaccurate subclass triggers the 10 working day correction duty under reg 8 and touches the penalty in reg 14 (fine not exceeding NZ$500 on conviction).

Insight 5: common misclassification patterns.

First, filing conventionally supplied low-risk devices that are supplied sterile as basic, overlooking the supply state. Second, filing devices that carry a scale but serve no clinical measuring purpose as measuring. Third, transplanting the Is and Im determination habits of the EU MDR to New Zealand without verifying the local conventions (practical estimate). Fourth, a Sponsor failing to update the record after the manufacturer changes the sterilisation method or the packaging state.

4. Practical recommendations

• GRZAN recommends setting the class and the Class I subclass as two independent fields in the classification determination table: first complete the class scan across the 22 Schedule 2 rules, then confirm the subclass by supply state and measuring function, avoiding a reversed order.
• GRZAN requires written manufacturer confirmation on two facts: whether the device is supplied sterile, and whether it has a measuring function serving a clinical purpose. Until they are answered, the subclass can only be guessed, and the cost of guessing falls on the Sponsor under the reg 7 declaration.
• Store the subclass determination basis (the manufacturer’s written confirmation plus the relevant GMDN term definition wording) in the technical documentation, for later corrections and disputes (practical estimate).
• Where a product line contains both sterile and non-sterile versions, split them into different records by supply state; do not file them together (practical estimate).
• Set up change monitoring: any change in sterilisation method, packaging state or measuring function enters the 10 working day correction trigger list under reg 8.
• When re-checking the correspondence with European classification, return first to the local rules of Schedule 2 of SR 2003/325; do not carry over foreign conclusions directly.

5. Verification checklist

• □ The class determination has been completed, confirming that the device is not hit by any higher-class rule of Schedule 2.
• □ It has been confirmed that the device is Class I within the 5 classes of reg 11.
• □ Written confirmation from the manufacturer has been obtained on whether the device is supplied sterile.
• □ Written confirmation from the manufacturer has been obtained on whether the device has a measuring function serving a clinical purpose.
• □ Where subclasses conflicted, the stricter subclass has been taken (practical estimate).
• □ Sterile and non-sterile versions within the same product line have been split into separate records.
• □ It has been confirmed that Class I does not involve the UPI requirement of reg 5(2).
• □ The feasibility of grouped entry for Class I records has been assessed under reg 5(3).
• □ Subclass-related changes have been brought into the 10 working day correction trigger mechanism.

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