Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
October 16, 2025
Approximately 5 minutes
New Zealand Medical Device Registration: The WAND Notification System and Sponsor Role
New Zealand Medical Device Registration: The WAND Notification System and Sponsor Role
Medical device regulation in New Zealand is overseen by Medsafe, the National Regulatory Authority (NRA) under the Ministry of Health (MoH). The system is governed by the Medicines Act 1981 and the Medicines (Database of Medical Devices) Regulations 2003. New Zealand's approach differs from many other markets as it operates primarily on a post-market notification system, with no formal pre-market review required in most cases.
The WAND Notification System
The key regulatory step for market access is the notification of the device in the Web Assisted Notification of Devices (WAND) database.
- Timeline: All medical devices must be notified in the WAND database within 30 days of commercialization (supply) in New Zealand.
- Approval Type: This is a notification process, not a formal pre-market approval. Medsafe does not currently charge fees for product notifications or annual retention.
- Duration: Registrations in WAND do not expire, provided post-market surveillance requirements are continually met.
Role of the New Zealand Sponsor
Foreign manufacturers must appoint a New Zealand-based Sponsor to act as their legal representative. The Sponsor is responsible for:
- Listing the medical device in the WAND database.
- Communicating with Medsafe on the manufacturer's behalf.
- Maintaining the required technical documentation.
Conformity Assessment and Documentation
While there is no formal pre-market review, the Sponsor must maintain technical documentation to demonstrate the device's safety and efficacy, as Medsafe may request this information at any time. This documentation includes:
- Proof of Reference Country Approval: New Zealand relies on approvals from recognized Reference Countries, including the USA, Canada, the European Union (EU), Australia, and Japan. Evidence of approval from one of these jurisdictions must be submitted as part of the listing process.
- Quality System Documentation: Proof of a compliant Quality Management System (QMS), such as an ISO 13485 certificate or an audit report from a recognized authority (e.g., FDA Establishment Inspection Report).
- Essential Principles: Documentation proving the device complies with the Essential Principles of safety and performance.
Regulatory Context (Mutual Recognition)
New Zealand has a close relationship with Australia, sharing the same classification rules (Class I, IIa, IIb, III, AIMD). Devices listed on the Australian Register of Therapeutic Goods (ARTG) can generally use this listing as the primary proof of Reference Country approval for their WAND notification, simplifying market access under the spirit of the Trans-Tasman Mutual Recognition Arrangement (TTMRA).
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Approximately 5 minutes
New Zealand Medical Device Classification: GHTF-Based Risk Rules
New Zealand's medical device classification is based on **GHTF guidelines** (similar to Australia/EU), dividing devices into Class I, IIa, IIb, III, and AIMD based on risk factors like invasiveness and duration of use. The classification is determined by applying **22 specific rules** outlined in **Schedule 2 of the Medicines (Database of Medical Devices) Regulations 2003**, starting from the highest risk rule and working backwards.
Approximately 5 minutes
New Zealand Medical Device Advertising: Compliance and Professional Use Restrictions
New Zealand medical device advertising is regulated by the **Medicines Act 1981**, though it lacks a formal review process. Manufacturers are expected to self-comply, ensuring all claims are truthful. Crucially, advertising for devices designated **'professional use only'** must be strictly limited to qualified practitioners and cannot appear on public-facing channels like social media or general publications. All labeling must be in **English**.
Approximately 5 minutes
New Zealand Post-Market Surveillance: Sponsor's Role in Medsafe Vigilance and Adverse Event Reporting
Post-Market Surveillance (PMS) is mandatory in New Zealand under the **Medicines Act**, requiring the **New Zealand Sponsor** to manage adverse event reporting and recalls. While distributors primarily report incidents, the Sponsor is responsible for ensuring all **Adverse Events (AEs)** are reported to Medsafe promptly. For incidents with the potential to cause serious injury or death, a final report must be submitted within **30 days** of the initial report.