Supporting Global Medical Device Companies in a Growing Healthcare Market

Qualtech is excited to announce the opening of our 15th office, with New Zealand now added to our service coverage.

This expansion strengthens our ability to support global healthcare companies exploring opportunities across Asia Pacific and Oceania, including regulatory entry, local representation, and market access support in New Zealand.

In medical device industry, New Zealand is considered one of the more accessible regulatory environments among developed healthcare markets, while still offering a stable and growing healthcare ecosystem.

 

New Zealand Regulatory Pathway Overview

A streamlined medical device entry framework

Medical devices in New Zealand are regulated by Medsafe, under the Medicines Act 1981 and the Medicines (Database of Medical Devices) Regulations 2003.

Unlike many other markets, the regulatory pathway focuses primarily on device notification rather than pre-market approval.
 

Key regulatory features

• No pre-market approval required for medical devices before commercialization
• Devices must be notified in the WAND database (Web Assisted Notification of Devices) to be legally supplied in New Zealand
• Listing must be completed within 30 days of placing the device on the New Zealand market
• WAND notification is free, and there is no licence or approval issued
• Notification requires only a device declaration under Regulation 7 of the Medicines (Database of Medical Devices) Regulations 2003
• Medsafe may request technical documentation if needed to verify device safety
   

Local sponsor requirement

Foreign manufacturers must appoint a New Zealand-based Sponsor, who acts as the local legal representative and is required to place medical devices on the New Zealand market. With its local presence, Qualtech enables manufacturers to establish this required local representation, ensuring a smoother and compliant entry into New Zealand.

The Sponsor is responsible for:

• Submitting device notifications to WAND
• Maintaining regulatory compliance
• Communicating with Medsafe when required
• Managing post-market obligations such as recalls, corrective actions, labelling, and advertising compliance

Sponsors must also ensure devices are safe, properly labelled, and compliant with relevant New Zealand regulations.
 

Globally familiar classification system

New Zealand follows the Global Harmonisation Task Force (GHTF) risk classification scheme, which is broadly aligned with regulatory models used in:

• European Union
• United States
• Australia

Medical devices are classified based on risk level and intended use, considering factors such as invasiveness, duration of contact, and impact on the patient.

The classification system includes:

• Class I – Low risk (e.g., basic or non-invasive devices)
• Class IIa – Low to medium risk
• Class IIb – Medium to high risk
• Class III – High risk (e.g., life-supporting or implantable devices)
• AIMD – Active implantable devices (highest risk)

Sponsors are responsible for determining the correct classification using rule-based criteria, and the highest applicable risk class must be applied.

 

Snapshot of New Zealand's healthcare market

Beyond regulatory accessibility, New Zealand also offers a stable and growing healthcare ecosystem.

Several structural trends are increasing demand for healthcare services, infrastructure, and medical technologies.

Healthcare spending and system scale

• New Zealand spends about 10% of GDP on healthcare, broadly in line with other OECD economies
• Health expenditure reached roughly NZD 46B (≈ USD 26.5B) in 2025
   

Strong public funding and national investment

Healthcare remains a key government priority, with substantial public spending allocated through the national health budget.

• Government continues to increase investment in health services and system capacity
• Policy priorities include faster cancer treatment, improved emergency access, and shorter waiting times
   

Aging population driving long-term demand

New Zealand's population is growing and aging, increasing demand for healthcare services and medical technologies.

This trend is a major driver of future healthcare investment and system expansion.
 

Expanding private healthcare activity

The private sector is playing a growing role in service delivery.

• Private hospitals performed 232,000 elective procedures in FY2025
• Public health services increasingly outsource procedures to private providers to address capacity constraints
   

Rising out-of-pocket healthcare spending

Patient spending on healthcare has also increased significantly.

• Out-of-pocket healthcare spending rose from NZD 2.9B (≈ USD 1.7B) in 2015
• Estimated to reach NZD 5.1B (≈ USD 2.93B) in 2025
   

National infrastructure investment in healthcare

New Zealand is implementing a 10-year national health infrastructure investment roadmap to expand and modernize healthcare facilities.

The plan targets upgrades across:

• Rural hospitals and community hubs
• Urban ambulatory centers
• Specialist hospitals and treatment sites
• Diagnostic and treatment infrastructure
• Oncology services
• Digital and virtual care systems
   

Growing focus on digital health and healthcare technologies

New Zealand's health infrastructure planning also highlights the need for improved diagnostic capability, digital health systems, and advanced medical technologies. These investments aim to improve healthcare productivity, expand service capacity, and modernize hospital infrastructure.
 

Healthcare capacity pressure creates technology demand

Despite strong public funding, the healthcare system is facing growing pressure from rising patient demand and capacity constraints. Increasing waiting times and infrastructure gaps are encouraging greater collaboration between public and private providers, creating opportunities for medical technologies that improve efficiency, diagnostics, and treatment capacity.
 

Strong healthcare performance among OECD countries

International comparisons also highlight New Zealand’s relatively strong health system performance. OECD indicators show that the country performs above the OECD average on many healthcare outcome and system indicators, supported by high public coverage and stable healthcare funding.

• Health expenditure per capita reached USD 6,061 PPP
• Life expectancy is above the OECD average

 

How Qualtech supports companies entering New Zealand

With our new office in New Zealand, Qualtech can support companies with:

• Local Sponsor representation
• WAND device listing and regulatory notification
• Regulatory compliance and market entry guidance

If your team is exploring the New Zealand market, contact us to learn how Qualtech can support your regulatory entry and local representation requirements.

 

References

1. Medsafe medical device regulation overview
2. Westpac Economics – Healthcare in New Zealand: The changing role of the private sector
3. Briefing to the Incoming Minister of Health January 2025 _ Ministry of Health NZ
4. Health Infrastructure Plan released _ Beehive.govt.nz
5. Health at a Glance 2025_OECD Indicators