Unique Product Identifier for Class III and AIMD Devices in New Zealand

Regulatory information verified as of 29 October 2026

1. Key takeaways

The original text of reg 5(2) of SR 2003/325 reads: “A unique product identifier for each Class III and Class AIMD medical device that is not an exempt medical device must be entered into the database.” This duty applies only to the 2 highest risk classes — Class III and Class AIMD (Active Implantable Medical Device). Class I, Class IIa and Class IIb do not need to record a unique product identifier (UPI), which is the reverse conclusion most often missed in practice.

Reg 5(4) gives the definition: “a unique product identifier for a medical device is a trade name or brand name, combined if the Director-General so requires, with a form of product identification.” The UPI is a trade name or brand name, not a coding system; the Director-General retains the discretion to require it to be combined with another form of product identification.

Under reg 11, Class I is lowest, Class IIa and Class IIb higher, and Class III and AIMD the highest 2 classes; reg 5(2) names only the latter two. On the official Medsafe page, the AIMD example is the implantable cardiac pacemaker and the Class III example the drug-eluting cardiac stent.

The New Zealand UPI is not the EU MDR’s UDI-DI: the former is a name-level identifier, the latter a device identification code from issuing agencies; entering a UDI-DI into the UPI field is a convention mismatch (practical estimate). IVDs likewise fall outside reg 5(2): Medsafe does not recognise any IVD risk classification model, IVDs uniformly use the classification code IVD, and they are in neither Class III nor AIMD (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: a triple narrowing of scope.

The first narrowing is by class: only Class III and AIMD, the other three classes carrying no such duty. The second is the exemption carve-out: the words that is not an exempt medical device exclude the 9 exemption categories of Schedule 1 — devices imported for clinical trials or for personal use need no UPI even if Class III. The third is mutual exclusivity with grouped entry: eligibility under reg 5(3) requires the devices to be Class I, Class IIa or Class IIb, so Class III and AIMD devices must record a UPI and be entered item by item, without bundling.

Insight 2: the UPI is a name-level identifier, not a code-level identifier.

Reg 5(4) defines the UPI as trade name or brand name. This divides levels with the manufacturer and Sponsor (New Zealand sponsor) names of reg 5(1)(b): (b) answers who made it and who sponsors it, the UPI answers which product it is. The UPI is also not on the GMDN’s level: reg 5(1)(c) requires the product description assigned within the GMDN system, a cross-company nomenclature; the UPI is the manufacturer’s own trade name or brand name within its product line. Both are mandatory, cannot substitute for each other, and the GMDN code cannot be entered as the UPI. Putting an EU UDI-DI or GS1 code into the UPI field mismatches the name and code levels, and if the Director-General requires combination under the second half of reg 5(4), there is no corresponding name formulation to fall back on (practical estimate).

Insight 3: the dormant power of the Director-General.

The words combined if the Director-General so requires describe a discretion not seen exercised to date. Its existence means the UPI convention is not permanently locked: the Director-General may require a model number, batch number or other form of identification for a given class of devices. Companies should keep the basis for the UPI value alongside the WAND records, so a change of convention can be re-entered quickly (practical estimate).

Insight 4: high-frequency errors in two directions.

One direction is over-filing: treating the UPI as universally mandatory and inventing identifiers for Class I, IIa and IIb devices as well, leaving the field inconsistent with the regulatory convention and possibly triggering the 10 working day duty under reg 8 at correction. The other is omission: Class III and AIMD devices skipped wholesale through a grouping process, with neither a UPI nor an item-by-item record. Both stem from the same misunderstanding — failing to read reg 5(2) and reg 5(3) together as mutually exclusive rules.

The exemption screening should be completed before the class determination: the exemption categories of Schedule 1 are unrelated to risk class, and screening for exemption first can terminate all subsequent entry actions in one stroke, including obtaining and filling in the UPI (practical estimate).

Insight 5: AIMD is not determined by risk cumulation.

The entry point for AIMDs is rule 20 of Schedule 2, and the basis of determination is the morphological feature of being active and implanted: under reg 3, an AIMD is an active device introduced into the body wholly or partly by surgical or medical intervention, or into a natural orifice, and intended to remain after the procedure. The same rule pulls two adjacent categories to Class III: implantable accessories of AIMDs, and active devices used to control, monitor or directly influence AIMD performance. All three must be entered item by item with a UPI under reg 5(2).

4. Practical recommendations

• GRZAN recommends listing the UPI as conditionally mandatory in the WAND entry work instruction, triggered by one test: Class III or AIMD and not exempt; otherwise leave the field blank.
• GRZAN requires an independent product master data table for Class III and AIMD devices covering at least trade name, brand name, model, GMDN code, classification conclusion and determination table number; the UPI is taken directly from the trade or brand name, without second coding.
• As soon as the class is determined as Class III or AIMD, abandon the grouped entry route of reg 5(3) immediately and schedule entry item by item (practical estimate).
• Obtain the official formulation of the trade name and brand name from the manufacturer, avoiding the entry of agent trade names or internal article numbers.
• For exempt devices (such as clinical trial imports or personal use), complete the exemption determination before entry, and stop the entry process the moment an exemption is hit.
• Archive the UPI value together with the determination table, place it in the s 38 evidence pack, and produce it on demand.

5. Verification checklist

• □ The device class has been confirmed as Class III or AIMD, and the rule 20 determination of Schedule 2 has been completed.
• □ The device has been confirmed as not among the 9 exemption categories of Schedule 1.
• □ The UPI value comes from the trade name or brand name, with no UDI-DI or GS1 code entered.
• □ The UPI field of Class I, IIa and IIb devices has been confirmed as left blank.
• □ Class III and AIMD devices have been scheduled for item-by-item entry, without applying grouped entry under reg 5(3).
• □ The basis for the UPI value has been archived together with the determination table.
• □ The official formulation of the trade name or brand name has been confirmed in writing by the manufacturer.

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