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.
November 16, 2025
Approximately 5 minutes
New Zealand Medical Device Classification: GHTF-Based Risk Rules
New Zealand Medical Device Classification: GHTF-Based Risk Rules
The classification of medical devices in New Zealand is a crucial step in the regulatory process, as it determines the level of scrutiny and documentation required for listing the product in the Web Assisted Notification of Devices (WAND) database. The classification system is overseen by Medsafe and is based on the internationally recognized Global Harmonization Task Force (GHTF) guidelines, which align closely with the Australian and European Union risk structures.
New Zealand Device Risk Classes
Medical devices are classified into four main categories, plus Active Implantable Medical Devices (AIMD), based on the level of risk they pose to the patient and user:
| Risk Class | Risk Description | Examples |
|---|---|---|
| Class I (Basic, Sterile, Measuring) | Low | Reusable surgical instruments, sterile dressings, volumetric urine bags. |
| Class IIa | Medium-Low | Hypodermic needles, suction equipment. |
| Class IIb | Medium-High | Ventilators, orthopaedic implants. |
| Class III | High | Drug-eluting cardiac stents. |
| AIMD (Active Implantable Medical Device) | Highest | Implantable pacemakers. |
The key factors determining a device's risk class include:
- Intended Use.
- Degree of Invasiveness (Non-invasive, Invasive, Implantable).
- Duration of Contact (Transient, Short-term, Long-term).
- Delivery Method and Applied Technologies.
The Classification Process (Schedule 2)
The risk classification is determined through a clear, structured approach using the 22 classification rules outlined in Schedule 2 of the Medicines (Database of Medical Devices) Regulations 2003.
- Rules Structure: The rules are organized to cover different device types. For instance, Rules 2–5 focus on non-invasive devices, Rules 6–9 cover invasive and implantable devices, and Rules 10–13 address active devices.
- Process of Elimination: To find the correct classification, applicants are advised to work through the rules using a process of elimination, starting from the highest-risk Rule (Rule 22) and working backward to Rule 2.
- Default Classification: If none of the 22 specific rules apply to the device, it defaults to the lowest risk classification: Class I Basic.
Manufacturers or their New Zealand Sponsor are responsible for accurately determining the classification, as Medsafe does not provide direct classification determinations. The chosen classification must be supported by the technical documentation provided by the manufacturer.
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Approximately 5 minutes
New Zealand Medical Device Registration: The WAND Notification System and Sponsor Role
Medical devices in New Zealand are regulated by **Medsafe** and listed in the **Web Assisted Notification of Devices (WAND)** database *after* commercialization. Unlike many jurisdictions, pre-market approval is generally not required. Foreign manufacturers must appoint a **New Zealand Sponsor** responsible for the WAND listing and maintaining conformity assessment evidence, which includes documentation like **ISO 13485** and approval from a **Reference Country** (e.g., Australia, EU, US).
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.