Medsafe GMP & WAND Notifications (New Zealand) – Keeping Medicines and Devices Visible to the Regulator

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated December 2025 • GMP, QMS, New Zealand Data Sheet & CMI, Traceability, WMS, UDI & Device Identification • Regulatory Affairs, QA, Operations, Supply Chain, New Zealand Sponsors

Medsafe GMP and WAND notifications are the twin pillars of New Zealand’s oversight of medicines and medical devices. For medicines, Medsafe applies GMP expectations aligned with international standards and relies on both its own audits and certificates from trusted regulators. For devices, the WAND (Web-Assisted Notification of Devices) database is how Medsafe keeps track of what’s actually on the New Zealand market, even though there is no full pre-market approval system comparable to the EU MDR or US 510(k). For sponsors and manufacturers, this means that “NZ compliance” is not just about labelling a product correctly: it’s about being visible in WAND where required and being able to show that your QMS, GMP and distribution controls stand up to Medsafe (and, often, overseas) scrutiny.

“In New Zealand, Medsafe wants two simple things: to know what you’re putting on the market, and to trust the system you used to make and distribute it.”

1) Who Medsafe Is and What It Oversees

Medsafe is the New Zealand Medicines and Medical Devices Safety Authority, part of the Ministry of Health. It is responsible for the regulation of therapeutic products supplied in New Zealand, including human medicines, related products and medical devices. Medsafe evaluates applications for medicine consent, conducts GMP inspections (often using overseas evidence), monitors adverse events and complaints, and oversees the WAND notification system for devices. While the New Zealand market is smaller than the EU or US, its regulatory expectations are firmly plugged into global frameworks—meaning that what you show Medsafe is often a subset of what you already need for EMA, MHRA, FDA, TGA or Health Canada.

2) Medsafe GMP – Alignment with Global Standards

For medicines, New Zealand GMP expectations are aligned with PIC/S and ICH principles and are broadly compatible with EU and other “stringent” regulatory regimes. Medsafe recognises GMP certificates and inspections from certain trusted regulators for overseas sites, and performs its own inspections of New Zealand-based manufacturers. Inspectors look at the same fundamentals you see elsewhere: facilities and utilities, process validation, cleaning, documentation and batch records, product quality reviews, deviations and CAPA, stability, data integrity and the maturity of the overall pharmaceutical quality system. For sponsors relying on overseas manufacture, Medsafe expects clear evidence of GMP status—not just an assurance from a supplier.

3) Medicine Registration, GMP and the New Zealand Data Sheet

Medicines supplied in New Zealand must generally have consent to market, supported by an application that includes quality, non-clinical and clinical information. The approved New Zealand Data Sheet and Consumer Medicine Information (CMI) describe how the product should be used. Behind that, GMP and QMS must ensure that the manufactured product matches what the data sheet claims: same composition, same quality, same stability profile. Medsafe may cross-check site details, batch release arrangements and GMP certificates against the application; inconsistencies (e.g. unapproved sites, un-notified changes) can trigger questions, conditions or refusal. For companies with global products, harmonising NZ dossiers with global CMC and GMP reality is essential to avoid surprises.

4) How Medsafe Approaches Overseas GMP Evidence

Most medicines used in New Zealand are manufactured overseas. Medsafe therefore relies heavily on information from other regulators: GMP certificates, inspection reports and listings under PIC/S or comparable frameworks. However, this is not blind acceptance: Medsafe still expects the New Zealand sponsor to understand where the product comes from, maintain oversight of suppliers and CMOs, and act if overseas GMP status changes. “We thought the EU/FDA handled that” is not a defensible position. Sponsors should have supplier qualification records, quality agreements and change-control processes that ensure GMP-dependent changes at overseas sites are reflected in New Zealand’s regulatory and operational controls.

5) The WAND Database – What It Is (and What It Isn’t)

WAND (Web-Assisted Notification of Devices) is Medsafe’s online database for device notifications. Most medical devices (and some related products) supplied in New Zealand must be notified in WAND by the New Zealand sponsor. Notification is not a marketing authorisation or quality approval; Medsafe does not routinely assess each device before it is placed on the market. Instead, WAND acts as a registry: it tells Medsafe which devices are on the market, who is responsible for them locally, and how to contact the sponsor if safety or performance issues arise. From a compliance perspective, failing to notify can still have serious consequences, including enforcement action and procurement barriers, even though WAND itself is “just” a notification system.

6) Who Must Use WAND and When

The New Zealand sponsor—usually the local legal entity that imports, distributes or markets the device—is responsible for WAND notification. In general, devices must be notified within defined timeframes after being supplied or before certain activities commence. Sponsors need to provide basic information: device name, model, classification, intended use, manufacturer details, and contact information. For global companies, this often means a New Zealand affiliate or partner must coordinate with global regulatory and master data teams to ensure the WAND record matches the device’s global identity and labelling. WAND is not a one-time task: when devices change, are discontinued or replaced, the sponsor is expected to update or cancel notifications so the database remains accurate.

7) WAND vs EU MDR / US 510(k) – Different Models, Same Need for Control

New Zealand’s model for devices relies on notification and post-market oversight, contrasted with the EU MDR’s CE-mark-based pre-market approach or FDA’s 510(k)/PMA regimes. That does not mean New Zealand is unconcerned with safety or manufacturing quality; it means the emphasis is on having a clear line of accountability to the sponsor and responding quickly when issues arise. For companies used to CE or FDA pathways, WAND can feel “light”—but the underlying expectation is that devices meet recognized standards, are manufactured under suitable QMS/GMP/ISO controls, and have evidence to back claims. If a serious incident occurs, Medsafe may look at global approvals, standards, post-market data and the sponsor’s QMS to decide what happens next.

8) Integration with QMS, Traceability and UDI/GTIN

WAND is only as useful as the sponsor’s internal data. To keep the regulator informed and recalls manageable, sponsors need robust product master data, device identification and traceability across ERP, WMS and labelling systems. For many device categories, global Unique Device Identification (UDI) regimes and GS1 GTINs provide a strong backbone: the same IDs can be used in WAND entries, internal systems and hospital procurement databases. The sponsor’s QMS should define how device identity is assigned, controlled, and linked to WAND records; otherwise, mismatches between notification, labelling and physical product quickly undermine confidence in both regulatory and customer audits.

9) Complaints, Recalls and Post-Market Surveillance

For both medicines and devices, Medsafe expects sponsors to operate robust post-market systems: collecting, investigating and trending complaints and adverse events; managing corrective actions and recalls; and communicating safety issues to the regulator and the market. In the device space, WAND acts as a contact and classification anchor when Medsafe needs to follow up on incident reports or risk communications. For medicines, complaint and PV data should tie back to the New Zealand Data Sheet, local pack and batch information. Internal QMS processes should ensure that signals from New Zealand (even if volumes are small) feed into global safety, quality and design change decisions, not just local fixes.

10) Medsafe Audits and Inspection Themes

Medsafe’s inspection approach is risk-based and often coordinated with overseas evidence, but common themes mirror other regulators: data integrity, adequacy of documentation, validation (process, cleaning, analytical), change control, deviation and CAPA quality, supplier and CMO oversight, and alignment between practice and registered details. For New Zealand sponsors, Medsafe may focus heavily on how well they understand and control their supply chains—particularly when product is manufactured offshore. Inspectors will often test whether the local QMS brings together global information (e.g. overseas GMP inspection outcomes, recalls, changes) into a coherent local picture, as opposed to simply assuming the “head office” has it covered.

11) Working with Distributors, Importers and CMOs

Many companies operate in New Zealand through distributors or local partners. From Medsafe’s perspective, these sponsors still need to have clear, documented arrangements that define who is responsible for GMP, WAND notification, complaint handling, recalls, labelling and compliance with the New Zealand Data Sheet. Quality agreements and commercial contracts should reflect those responsibilities. Where manufacturing or testing is outsourced, the sponsor must show how it assesses and monitors the GMP and QMS of those providers—using audits, certificates, performance metrics and change notifications. A sponsor that cannot explain what its partners are doing, or how it learns about problems, will struggle to convince Medsafe that it is in control.

12) Managing Change – Device Families, Generations and WAND Updates

Devices change frequently: new models, firmware updates, design tweaks, packaging adjustments. Sponsors must decide when these changes are significant enough to require new or updated WAND notifications, updated instructions, or changes to internal traceability. The sponsor’s QMS should include a structured change-control process that evaluates:

• Whether the intended use or risk profile has changed.
• Whether global regulatory submissions or listings (e.g. CE certificates, FDA clearances) are affected.
• Whether WAND notifications need to be updated or new entries created.
• How to keep distributors, hospitals and end users informed.

Inconsistent WAND entries across device “generations,” or notifications that no longer match reality, create confusion during incidents, procurement and audits.

13) New Zealand in a Global Regulatory Strategy

For many companies, New Zealand is one node in a broader ANZ or APAC strategy, often aligned with Australia’s TGA decisions. While Medsafe pays close attention to TGA, EMA, FDA and other regulators, sponsors should not assume that decisions in larger markets automatically “solve” New Zealand. NZ-specific labelling (Data Sheet/CMI), local sponsors and WAND obligations mean that some tailoring is inevitable. A sensible strategy treats New Zealand as a small but high-leverage market: the systems and traceability you put in place to keep Medsafe comfortable can often be reused to strengthen your global QMS, especially for batch/lot tracking, device identification and distributor oversight.

14) Common Pitfalls and How to Avoid Them

Patterns that routinely cause trouble in New Zealand include:

• Assuming WAND notification equals regulatory “approval” and neglecting ongoing QMS responsibilities.
• Letting WAND records go stale when devices change, are discontinued or rebranded.
• Underestimating the need for documented oversight of CMOs and overseas manufacturers.
• Maintaining separate, conflicting product identifiers across ERP, labelling, WAND and distributors’ systems.
• Treating New Zealand complaints and incidents as unimportant because volumes are small.

Most of these pitfalls can be avoided by integrating NZ-specific obligations into the same global quality, regulatory and master-data governance structures used for larger markets, rather than trying to manage New Zealand as an afterthought.

15) Implementation Roadmap – Making NZ Compliance a Normal Output of the System

A practical roadmap for Medsafe GMP and WAND readiness includes:

• Mapping all New Zealand medicines and devices to their global identifiers, manufacturers, CMOs and distributors.
• Creating (or cleaning up) WAND notifications so they match current products, sponsors and configurations.
• Ensuring New Zealand Data Sheets and CMI match global labelling and formulation reality.
• Aligning QMS processes (complaints, change control, recalls, supplier management) to capture NZ-specific data and feed it into global decisions.
• Integrating WAND IDs and NZ product information into ERP, WMS and labelling systems so traceability is seamless.

The aim is that when Medsafe asks “who’s responsible for this product, how was it made, and where is it?”—your systems can answer quickly and consistently, without a scramble through spreadsheets and local inboxes.

16) FAQ

Q1. Does WAND notification mean Medsafe has approved my device?
No. WAND is a notification system, not a pre-market approval or certification. It records that a device is on the market and who the New Zealand sponsor is, but sponsors remain responsible for safety, performance, QMS and compliance with applicable standards and laws.

Q2. Do all devices need to be notified in WAND?
Most medical devices and some related products supplied in New Zealand require WAND notification, with specific exemptions defined in Medsafe guidance. Sponsors should confirm whether their products are in scope and not assume that small volume or low risk automatically exempts them.

Q3. If my medicine is made overseas and approved in the EU or Australia, do I still need to worry about GMP for New Zealand?
Yes. Medsafe may recognise overseas GMP evidence, but the New Zealand sponsor must still ensure manufacturers are compliant, monitor changes and issues, and keep local dossiers and quality systems aligned with how the product is actually made and controlled.

Q4. How often should WAND notifications be reviewed or updated?
At minimum, whenever there is a significant change to the device, sponsor, manufacturer or supply status. Many sponsors also schedule periodic reviews to catch drift and ensure discontinued products are removed and new variants are properly recorded.

Q5. What is a practical first step for a company new to the New Zealand market?
Identify your New Zealand sponsor, map all products you intend to supply to their global identifiers and manufacturing sites, confirm WAND obligations, and integrate NZ data into your global QMS, ERP and labelling systems. This avoids building a separate, fragile “NZ-only” process that is hard to maintain.

Related Reading
• New Zealand & ANZ: New Zealand Data Sheet & CMI | UDI in Australia | TGA | TGA GMP Clearance
• QMS & Supply Chain: Quality Management System (QMS) | Supplier Qualification | Quality Agreements | Traceability | Mock Recall
• Systems & Data: WMS | MES | LIMS | Data Integrity