Risk Classification Rules for Medical Devices in New Zealand

1. Overview of Classification System

Medical devices in New Zealand are classified according to risk to determine the level of regulatory controls and conformity assessment required. The classification rules are set out in the Medicines (Classification of Medical Devices) Regulations and are closely aligned with those in the European Union (EU) Medical Devices Directive and In Vitro Diagnostic Medical Devices Directive (as referenced at the time of the guidance). Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-7RiskClassification.asp

Non-IVD devices are classified into four classes: I (lowest risk), IIa, IIb, and III (highest risk). IVD devices are classified into four classes: 1 (lowest), 2, 3, and 4 (highest). Classification is based on the manufacturer's intended purpose, taking into account factors such as duration of contact with the body, degree of invasiveness, anatomical location affected, and potential consequences of failure or misuse. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-7RiskClassification.asp

2. Classification Rules for Non-IVD Devices

The 22 classification rules for non-IVD devices are divided into non-invasive devices, invasive devices, active devices, and special rules. Key examples include:

• Non-invasive devices: Class I unless intended for channeling or storing blood/body fluids (IIa), or modifying biological/chemical composition (IIb/III depending on risk).
• Invasive devices: Class I for short-term (≤60 days) superficial body orifice contact; higher classes for longer duration, surgical invasiveness, or implantation (up to III).
• Active devices: Class I for low energy/low risk; IIa/IIb for diagnostic/therapeutic energy application; III for critical functions (e.g., life-support, emission of ionizing radiation).
• Special rules: Cover devices with medicinal substances (III), biological origin (III), absorption (III), contraception (IIb/III), or specific high-risk features.

The highest applicable rule determines the class. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-7RiskClassification.asp

3. Classification Rules for IVD Devices

IVD devices are classified using seven rules, primarily based on the intended use and the risk posed by incorrect results:

• Class 1: Low individual/public health risk (e.g., general laboratory reagents, instruments without specific high-risk claims).
• Class 2: Moderate individual risk/low public health risk (e.g., most self-test kits, many clinical chemistry tests).
• Class 3: High individual risk/moderate public health risk (e.g., tests for sexually transmitted agents, genetic tests).
• Class 4: High individual and public health risk (e.g., high-risk blood screening, confirmatory tests for serious conditions like HIV, hepatitis).

Special considerations apply to controls/calibrators and near-patient/self-testing IVDs. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-7RiskClassification.asp

4. Implications of Classification

Higher classes require more stringent conformity assessment (e.g., third-party involvement for Class IIa and above non-IVD, and most IVD classes). Class I non-IVD devices (self-declared) and Class 1 IVDs generally need only manufacturer self-assessment. Classification determines the level of evidence required for safety and performance claims. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-7RiskClassification.asp

5. Borderline and Combination Products

For products that are borderline (e.g., device with ancillary medicinal substance), classification as a medical device or medicine depends on the principal mode of action. Combination devices incorporating medicinal substances are typically classified as Class III. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-7RiskClassification.asp

6. Additional Notes

Classification is the responsibility of the manufacturer/sponsor and must be justified in technical documentation. Medsafe may review classifications during market entry or post-market surveillance. The rules facilitate alignment with international systems (especially Australia and EU) for mutual recognition of assessments. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-7RiskClassification.asp

This risk-based approach ensures appropriate regulatory oversight proportional to the potential harm from device failure or misuse, supporting safe access to medical technologies in New Zealand. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-7RiskClassification.asp