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November 16, 2025
Approximately 5 minutes
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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