New Zealand Medsafe Medical Device Registration Guide: WAND, Sponsor Duties, and Reliance Pathways

Why New Zealand Is One of the Most Accessible Developed Markets

New Zealand regulates medical devices through Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, under the Medicines Act 1981 and the Medicines (Database of Medical Devices) Regulations 2003. Unlike most developed markets, New Zealand does not require pre-market approval or licensing for medical devices. There is no technical review, no registration certificate, and no fee for market entry.

Instead, the system relies on post-market controls: devices must be notified in Medsafe's Web-Assisted Notification of Devices (WAND) database, and the New Zealand Sponsor is legally responsible for device safety, vigilance, and regulatory compliance. This makes New Zealand one of the fastest markets to enter for manufacturers who already hold approvals from recognized reference countries.

However, "fast" does not mean "lax." Medsafe actively monitors device safety, investigates adverse events, and can order product recalls. The Sponsor bears significant legal responsibility and must have the infrastructure to support post-market obligations.

Regulatory Framework Overview

Governing Legislation

Medsafe is a business unit of the Ministry of Health and is responsible for regulating medicines, medical devices, and other therapeutic products.

Key Principles

• No pre-market approval: Devices are not reviewed for safety and efficacy before market entry
• Notification-based: Devices must be entered in WAND within 30 calendar days of a person or organization becoming the sponsor
• Reference country recognition: Medsafe accepts certifications from FDA, EU Notified Bodies, Health Canada, TGA (Australia), and PMDA (Japan) as evidence of conformity
• Post-market focus: Compliance relies on the manufacturer meeting Essential Principles of Safety and Performance and the Sponsor maintaining ongoing vigilance
• Free of charge: There is no fee for WAND notification or annual retention

Medical Device Classification in New Zealand

GHTF Risk Classification

New Zealand follows the Global Harmonisation Task Force (GHTF) risk classification scheme, which aligns with the regulatory models used in Australia, the EU, and many other jurisdictions:

IVD Classification

Medsafe does not recognize any IVD risk classification model and has established a single classification for all IVDs. IVDs are currently exempt from mandatory notification to WAND, but they may be voluntarily notified.

Exempt Devices

Devices exempt from WAND notification are listed in Schedule 1 of the Medicines (Database of Medical Devices) Regulations 2003. Common exemptions include:

• Custom-made devices (when made for a particular patient)
• Devices for export only
• Devices for use in clinical trials (covered under separate provisions)

The WAND Notification Process

Step 1: Appoint a New Zealand Sponsor

Foreign manufacturers without a legal entity in New Zealand must appoint a Sponsor based in New Zealand. The Sponsor must have a registered business or principal place of business in New Zealand.

The Sponsor is the entity legally responsible for the device and is the sole liaison between the manufacturer and Medsafe. An importer, exporter, or manufacturer can act as a Sponsor if they are located in New Zealand and operate a business there.

Sponsor responsibilities include:

• Notifying devices to WAND
• Maintaining the accuracy of information in WAND
• Ensuring devices are safe for their intended purpose
• Cooperating with Medsafe on adverse event investigations
• Supporting recalls and corrective actions
• Maintaining technical documentation available for Medsafe inspection

Step 2: Gather Required Documentation

Before notifying a device to WAND, ensure you have:

• Proof of reference country approval: Certification from an EU Notified Body, FDA clearance/approval, Health Canada device license, TGA (Australia) inclusion, or PMDA (Japan) approval
• Declaration of conformity: The manufacturer's declaration that the device meets the Essential Principles of Safety and Performance
• ISO 13485 certificate: Evidence of the manufacturer's quality management system
• GMDN code: The Global Medical Device Nomenclature code for the device
• Device labeling: Labels and instructions for use compliant with New Zealand requirements
• Risk classification documentation: Rationale for the assigned GHTF risk class

Medsafe does not routinely review this documentation during the notification process, but may request it at any time. The Sponsor must have it readily available.

Step 3: Create a WAND Sponsor Account

1. Register as a Sponsor in the WAND database at medsafe.govt.nz
2. Receive a 5-digit Sponsor ID number and password
3. Confirm your Sponsor Details are correct

Step 4: Notify the Manufacturer

Before notifying individual devices, the Sponsor must first notify the manufacturer:

1. Log into WAND using the 5-digit Sponsor ID and password
2. Confirm Sponsor Details are correct
3. Click "Notify a New Manufacturer"
4. Enter: manufacturer's name, street address, city, country, telephone number, email address, website address
5. Review and submit

Step 5: Notify Each Device

1. Log into WAND
2. Click "Add New Device"
3. Complete all mandatory fields (indicated by red asterisks):
   • Sponsor's Own Reference (use a descriptive name that includes brand and description)
   • Manufacturer details (linked to the previously notified manufacturer)
   • GMDN code
   • Risk classification
   • Device description
   • ARTG number (if the device is also registered in Australia — optional field)
4. Submit the notification

Important: When notifying devices of the same kind (same manufacturer, same GMDN code, same risk class, and Class I, IIa, or IIb), the Sponsor can notify by kind rather than by individual device.

Step 6: Maintain WAND Records

• Any changes to notified information must be updated within 10 working days of the change ceasing to be accurate or complete
• This includes changes to manufacturer details, device descriptions, classification, and sponsor information
• If a device is no longer supplied in New Zealand, the notification should be made obsolete

Sponsor Obligations in Detail

Regulatory Compliance

Under Regulation 7 of the Medicines (Database of Medical Devices) Regulations 2003, when notifying a device the Sponsor declares that:

1. The product is a medical device as defined in the regulations
2. The Sponsor has assigned the correct risk category to the device
3. The Sponsor will recommend devices only for their intended use
4. The information provided was accurate and complete

Vigilance and Adverse Event Reporting

Medsafe takes a proactive approach to post-market monitoring. The Sponsor must:

• Report adverse events: Any adverse events suspected to be due to use of a medical device should be reported to Medsafe
• Cooperate with investigations: Medsafe assigns an investigator who works directly with the Sponsor and manufacturer to resolve issues
• Support recalls: If Medsafe determines a device should be recalled, the Sponsor must cooperate with the recall process
• Maintain complaint records: Document all complaints and how they were resolved

Medsafe accepts adverse event reports from:

• Patients and their carers or relatives
• Healthcare professionals
• New Zealand suppliers and manufacturers
• Accident Compensation Corporation (ACC)
• Overseas regulators

Technical Documentation

The Sponsor must keep at the disposal of Medsafe:

• Technical File or Design Dossier for each notified device
• Reports from critical evaluations of clinical data
• Evidence of compliance with the Essential Principles of Safety and Performance
• Quality management system certificates

Labeling Requirements

Medical devices in New Zealand must comply with labeling requirements that include:

• Device name and description
• Manufacturer name and address
• Intended purpose
• Storage and handling instructions
• Expiry date (if applicable)
• Batch or lot number
• Instructions for use
• Any warnings or contraindications

Advertising Compliance

Advertising of medical devices in New Zealand must comply with the Therapeutic Products Advertising Code. Claims must be consistent with the device's intended purpose and supported by evidence.

Changing Sponsors

Changing the New Zealand Sponsor requires cooperation between the outgoing and incoming Sponsors:

1. Outgoing Sponsor (Sponsor A) must mark all device notifications as obsolete in their WAND account
2. Incoming Sponsor (Sponsor B) must re-notify all devices under their own WAND account
3. Timeline: Sponsor B must notify the devices within 30 working days of becoming the new sponsor

Critical point: Medsafe cannot reassign WAND notifications from one sponsor to another. The process requires complete re-notification. This means:

• There is no gap in market authorization (re-notification can proceed while devices continue to be sold)
• The new Sponsor must have all device documentation ready before initiating the transfer
• Both Sponsors should coordinate closely to minimize the transition period

Reliance Pathways and International Recognition

Reference Country Recognition

Medsafe accepts evidence of conformity from the following recognized regulatory authorities:

Manufacturers with approvals from any of these reference countries can leverage that evidence for New Zealand market entry without additional pre-market review.

Trans-Tasman Mutual Recognition Agreement (TTMRA)

New Zealand and Australia have a mutual recognition agreement under the Closer Economic Relations (CER) trade agreement. Under the TTMRA:

• Goods that can be legally sold in Australia can generally be sold in New Zealand, and vice versa
• For medical devices, the TTMRA is less straightforward because the two countries have different regulatory frameworks
• Australia's TGA requires pre-market approval for most devices, while New Zealand does not
• Despite this, having TGA approval is strong evidence of conformity for the New Zealand WAND notification

MDSAP Membership

New Zealand is a member of the Medical Device Single Audit Program (MDSAP), alongside the US, Canada, Brazil, Japan, and Australia. MDSAP certification is recognized as evidence of quality management system compliance for New Zealand market entry.

Timelines and Costs

Estimated Timeline

Estimated Costs

This makes New Zealand one of the most cost-efficient developed markets for medical device market entry.

New Zealand Healthcare Market Context

Healthcare System

New Zealand has a publicly funded healthcare system administered by Health New Zealand (Te Whatu Ora), which replaced the former District Health Boards in 2022. The public system provides free or subsidized healthcare to all New Zealand residents. Private healthcare exists alongside the public system, particularly for elective procedures.

Market Size and Opportunity

• Population: Approximately 5.3 million
• Healthcare spending: Approximately 10% of GDP
• Medical device market: Estimated at USD $1.0–1.3 billion annually
• Key sectors: Orthopedics, cardiovascular, diagnostic imaging, surgical equipment
• Growth drivers: Aging population, increasing chronic disease prevalence, digital health adoption

Procurement

• Public hospital procurement is managed centrally through Health New Zealand
• Pharmaceutical Management Agency (PHARMAC) has expanded its scope to include some medical device procurement
• District-level procurement still occurs for certain categories
• Private hospital procurement follows standard commercial channels

Practical Considerations for Market Entry

Do's

• Leverage existing approvals: If you have FDA, CE, TGA, or Health Canada approval, use it. The New Zealand system is designed to recognize these approvals
• Choose your Sponsor carefully: The Sponsor holds significant legal responsibility. Select a Sponsor with regulatory expertise, not just a logistics company
• Maintain documentation: Even though Medsafe does not routinely review technical files, they may request documentation at any time. Have it ready
• Plan for adverse event reporting: Establish clear procedures for how your Sponsor will handle complaints, adverse events, and recalls
• Consider New Zealand as part of an APAC market entry strategy: The fast timeline and low cost make New Zealand an excellent first market for an Asia-Pacific expansion

Don'ts

• Don't assume "no pre-market approval" means "no regulation": Medsafe has strong post-market powers and will use them
• Don't skip WAND notification: Selling a device without WAND notification is a regulatory violation
• Don't forget labeling requirements: Devices must have appropriate English-language labeling
• Don't neglect ongoing compliance: WAND records must be kept current, changes must be notified within 10 working days, and adverse events must be reported promptly
• Don't overlook additional regulatory regimes: Some devices may also need to comply with electrical safety, radiation, hazardous substances, or radiocommunications requirements

Frequently Asked Questions

How long does WAND notification take? The online submission is completed the same day. The 30-day clock starts from when the device first arrives in New Zealand or when the sponsor relationship begins.

Is IVD notification mandatory? No. IVDs are currently exempt from mandatory WAND notification but may be voluntarily notified.

Can I use my Australian TGA approval? Yes. TGA inclusion is recognized as a reference country approval and is strong evidence of conformity for WAND notification.

What if my device is recalled in another country? Medsafe monitors international regulatory actions. If your device is recalled in a reference country, Medsafe may contact the New Zealand Sponsor for information and potentially initiate its own investigation or recall.

Do I need a local clinical trial? No. New Zealand does not require local clinical data for WAND notification. Reference country approval is sufficient.

Can I sell while the WAND notification is being processed? The device must be notified within 30 days of becoming the sponsor, and this is generally interpreted as 30 days from when the device first arrives in New Zealand. You should plan to have WAND notification completed before commercial launch.

What happens if Medsafe requests my technical file? The Sponsor must provide the requested documentation. Failure to provide it can result in regulatory action, including removal of the device from the market. The Sponsor should always have the technical file available but should not release it to Medsafe without the manufacturer's written approval.