Understanding Medsafe’s Medical Device Risk Classification in New Zealand

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is the central Regulatory authority that oversees medical device regulations in New Zealand.

In New Zealand, medical devices are classified according to their potential risk(s) to the human body. They range from Class I, which are low-risk devices, to Active Implantable Medical Devices (AIMDs), which are high-risk devices. A New Zealand sponsor must identify the appropriate risk classification for their medical devices.

Recent changes to risk classification systems in Europe and Australia have resulted in discrepancies in risk classifications between these Regulatory regimes and New Zealand. Under the Trans-Tasman Mutual Recognition Arrangement (TTMRA) between Australia and New Zealand, medical equipment lawfully delivered in one country can be recognized and sold in the other without additional regulatory procedures, simplifying market entry for manufacturers targeting both markets. However, the absence of a similar arrangement with Europe means that recent regulatory changes there may not automatically align with New Zealand's classifications. Consequently, the same medical device could be classified differently in each region, posing challenges for manufacturers aiming to sell in both markets.

New Zealand’s Medical Device Risk Classification

The New Zealand medical device regulations have five (05) risk classes and two (02) sub-classes, as per the Global Harmonisation Task Force (GHTF) principles. These classes are based on the potential risk caused by medical devices when they are used according to the manufacturer’s instructions. The classes are outlined below.

New Zealand’s Medical Device Risk Classification Criteria

The risk classification guidelines outlined in Schedule 2 of the Medicines (Database of Medical Devices) Regulations, 2003 are used to determine medical device risk classification. When assigning a medical device risk classification, various aspects are considered, including the device’s intended function, its compatibility with other devices, and the level of risk involved in using it.

• Class I: These devices form the lowest level of medical device risk classification under the regulations.
• Class IIa and Class IIb: These devices Indicate progressively greater risk classification levels.
• Class III and Class AIMDs: These devices belong to the highest risk categories.

If a medical device falls under multiple risk classification rules, it is classified based on the highest level of risk classification applicable to it under the regulations.

Principles for the Application of Medical Device Risk Classification in New Zealand

• The regulations must be followed meticulously when determining the risk classification for a medical device, as per the risk classification rules outlined in Schedule 2.
• The classification of a medical device should consider its intended purpose.
• When a medical device is meant to be used alongside another device, each of the two (02) devices should be classified separately.
• Accessories associated with medical devices should be classified independently from the primary device.
• If software influences or operates in conjunction with a medical device, it receives the same risk classification as the device itself.
• In cases where a medical device is not exclusively designated for use in a specific part of the body, classification should prioritize the most critical specified use.
• If multiple risk classification rules are relevant to a medical device based on its intended purpose, the device is classified according to the highest level of risk.

Process of Medical Device Risk Classification in New Zealand, as Per Schedule 2

• Start by accessing Schedule 2 and reviewing its contents, which can be found online on the New Zealand Government Legislation Website.
• Schedule 2 outlines twenty-two (22) rules that are utilized for establishing the risk classification of medical devices.

Applying the Rules of Medical Device Risk Classification in New Zealand

• Utilize a systematic process of elimination to ascertain the risk classification.
• Start by navigating the twenty-two (22) rules, beginning with Rule 22, “Medical Devices that are Mammary Implants,” and proceed backward to Rule 2.
• Initiating from Rule 22 and progressing backward aids in excluding higher classifications, thereby facilitating an efficient determination.
• Devices not excluded by any rule are designated as Class I.
• Should you encounter difficulty in determining the risk classification, consult the device manufacturer. Medsafe is unable to determine the risk classification of medical devices.

For example, consider a cardiac guide catheter used to facilitate the delivery of other medical devices to the heart. This catheter is a single-use device and is inserted through the femoral artery, remaining inside the patient for roughly one (01) hour. This device will follow the following risk classification method:

By using this elimination process according to Schedule 2, the guide catheter is classified as Class IIa.

In summary, it is essential to adhere to the outlined principles when applying risk classification rules in New Zealand to ensure accurate classification of medical devices in New Zealand. By carefully considering the intended purpose, potential combinations with other devices, and the influence of software, manufacturers can determine the appropriate risk classification for their devices. This diligent approach not only facilitates Regulatory compliance but also contributes to the safety and efficacy of medical devices placed on the New Zealand market.

Explore how Freyr can assist you in navigating the risk classification process for medical devices in New Zealand. Our Regulatory experts will provide you with comprehensive support to ensure a compliant and successful New Zealand Medical device registration. Contact us to learn more!