Discontinued Medical Devices and WAND Record Status in New Zealand

1. Key takeaways

Regulatory information verified as of 29 October 2026. When a device is discontinued, the New Zealand approach is not to withdraw an approval but to change the WAND (Web Assisted Notification of Devices) record status from Active to Obsolete. This is not wordplay: New Zealand has no market approval system for devices, so there is no approval to revoke.

Medsafe’s advice to sponsors carries one key constraint: for reusable and implantable devices, do not mark the record Obsolete before the device can no longer be supported, repaired or serviced. Obsolete takes the record out of active use, while implant and reusable-device users may still need recalls, corrective actions or spare parts across the service life.

Exempt devices follow the same logic. Devices such as in vitro diagnostic devices (IVDs) are excused from mandatory notification, but where a sponsor notifies voluntarily, status maintenance matches mandatorily notified devices: Active to Obsolete after supply ceases.

The official position needs care: Medsafe records that the Director-General declared IVDs exempt from notification under Schedule 1(i), and also instructs that when notifying an IVD the classification code IVD is entered. The two coexist; GRZAN handles this uniformly as notifiable with classification code IVD, flagged as a practical estimate. Correspondingly, the 22 classification rules in Schedule 2 and the reg 5(2) UPI requirement for Class III and AIMD devices do not apply to devices coded IVD; Medsafe adds that voluntarily notified IVDs need not record animal-origin materials or formulation information.

One negative conclusion must be stated plainly: the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325) prescribe no statutory retention period for distribution records. Medsafe’s duty is purpose-based: keep records so all affected users can be contacted in a recall or corrective action; the period is governed by risk and device lifetime (practical estimate).

• Discontinued devices move from Active to Obsolete in WAND; there is no approval to withdraw.
• Reusable and implantable devices stay Active while they can still be supported, repaired or serviced.
• Voluntarily notified exempt devices, including IVDs, follow the same status maintenance logic.
• IVD-coded devices do not use the 22 Schedule 2 rules or the reg 5(2) UPI requirement (practical estimate).
• No statutory retention period exists for distribution records; the duty is purpose-based.

2. Legal basis

The instruments relevant to discontinued device records are set out below.

3. Expert insights

Insight 1: there is no such thing as withdrawing an approval, only a status field. SR 2003/325 creates notification duties only, not market access permissions; Medsafe states WAND is not an approval system and notification does not indicate assessment of a product’s quality, safety, efficacy or performance. On exit, the only lever is the record status field. This differs from the EU and US, where certificate cancellations or listing terminations must be processed; in New Zealand the object is a database status. The commonest confusion is writing that a New Zealand registration certificate has been revoked in customer communications or tender documents — wording which brushes against reg 10’s prohibition on implying official endorsement.

Insight 2: the instruction not to mark implantable devices Obsolete early is a patient-traceability rule. It addresses reusable and implantable devices: do not mark Obsolete before they can no longer be supported, repaired or serviced. It echoes the recall architecture: in the Recall Code, the Hazard Alert type applies only to implantable devices, because implants cannot be recovered and patients and clinical teams can only be reached by warning. Executability requires the sponsor to contact every implanted patient — exactly Medsafe’s stated purpose for distribution records. GRZAN’s judgement: for implantable devices the correct Obsolete trigger is not the last sale but the point at which the last implanted patient no longer needs follow-up and spare-part support.

Insight 3: the missing statutory retention period is both a freedom and a duty. With no period in the regulations, companies cannot justify destroying records by saying the statutory period has passed, nor refuse long-term retention by arguing the law requires only N years. GRZAN sets internal periods at expected device lifetime plus margin (practical estimate, not a statutory requirement), with a longer window for implantable devices. The benchmark is continuing liability: s 38(8) punishes selling before the safety evidence requirement is met with up to 6 months imprisonment or a fine not exceeding NZ$5,000.

Insight 4: status maintenance sits inside the reg 8 correction framework. Reg 8 requires correction within 10 working days when information in a record ceases to be accurate or complete; listed triggers include a manufacturer or sponsor name change and lapse of certification. Discontinuation changes the active-use state and sits in the same framework. Reg 9 additionally requires procedures ensuring ongoing compliance with reg 5, reg 6 and reg 8; GRZAN recommends making discontinuation assessment a fixed node rather than a judgement improvised during stock clearance.

4. Practical recommendations

• Make discontinuation a formal trigger. GRZAN advises stating in New Zealand notification procedures that a production stop, distribution agreement termination or zeroed stock triggers a status assessment, completed within 10 working days as a WAND update or a documented reasoned deferral.
• Set a deferred rule for implantable and reusable devices. GRZAN builds a support capability list recording spare-part supply years, repair arrangements and clinical follow-up requirements; while any item remains in force, the record stays Active.
• Set and document retention periods by risk. GRZAN advises stating in procedures that implantable devices are retained for expected lifetime plus margin and others per product liability and recall needs, written into reg 9 documents.
• Discontinuation does not lift s 38 liability. Devices sold remain in use, and the Director-General may still require evidence within 45 days; keep a retrievable technical package.
• Include exempt devices and voluntarily notified IVDs in status maintenance. Their records follow the same logic and cannot be left unattended because notification was optional; the classification code is IVD (practical estimate), the 22 Schedule 2 rules do not apply, and no Class III or AIMD UPI is entered.

5. Verification checklist

• □ Record status moves from Active to Obsolete after supply ceases, not from withdrawing an approval
• □ Implantable and reusable devices not marked Obsolete early while still supportable, repairable or serviceable
• □ Discontinuation-triggered status assessment documented in reg 9 procedures
• □ Status updates fall within the reg 8 10 working-day correction period
• □ Distribution retention periods set in writing (practical estimate), with a longer window for implantable devices
• □ All supplied users remain contactable, supporting recalls and Hazard Alerts
• □ Technical package retained for the 45-day s 38 duty, discontinued devices still in use
• □ Voluntarily notified exempt devices including IVDs are in scope of status maintenance; classification code IVD (practical estimate)
• □ Devices coded IVD are not subject to the 22 Schedule 2 rules and no reg 5(2) UPI is entered
• □ External wording avoids revoking a registration or approval (reg 10)

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 coordinates New Zealand sponsor arrangements, import requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com