Medical Device Regulations in New Zealand

Medical Device Regulation in New Zealand

Classification of Medical Devices in New Zealand

New Zealand classifies medical devices using a risk-based approach closely aligned with the EU and the FDA systems. Devices are categorized into the following risk classes:

• Class I: Low risk
• Class IIa: Low-to-moderate risk
• Class IIb: Moderate-to-high risk
• Class III: High risk

The classification depends on factors such as the intended use, duration of contact with the body, and the invasiveness of the device. Manufacturers must carefully determine their device's risk class to ensure compliance with Medsafe regulations and select the appropriate registration pathway.

Key Considerations for Classification

• Intended Purpose: How the device is designed to be used, including any medical claims.
• Invasiveness: Whether the device interacts with sterile areas of the body or the central circulatory system.
• Duration of Use: Whether the device is used temporarily, short-term, or long-term.

Meeting these classification requirements ensures the device complies with New Zealand's safety and quality standards, promoting confidence in the healthcare system.

New Zealand’s healthcare sector highly values innovative and safe medical technologies. Devices that align with these principles are compliant and well-received by healthcare professionals focused on improving patient outcomes.

Approval Process in New Zealand

Registration Process

In New Zealand, all medical devices must be registered in the Web-Assisted Notification of Devices (WAND) database within 30 days of being supplied to the market. Before registration, manufacturers should ensure all necessary documentation is prepared to demonstrate the safety and effectiveness of the product, as Medsafe may request this information during the process.

Unlike other countries, New Zealand does not require a comprehensive pre-market review of registration documents. Instead, a database notification and a declaration under Section 7 of the Medicines (Database of Medical Devices) Regulations 2003 are sufficient to bring products to market.

Many manufacturers opt to conduct parallel registrations in Australia and New Zealand, leveraging EU or US technical documentation. This approach streamlines the process and ensures compliance with both countries' regulatory frameworks, given the alignment between New Zealand’s Medsafe and Australia’s TGA requirements.

Why Choose New Zealand?
New Zealand’s streamlined process and reliance on international certifications make it an attractive market for manufacturers seeking efficient regulatory pathways. By leveraging existing documentation, manufacturers can access the market without the extensive pre-market scrutiny required in other regions.

Qserve can support you throughout the process, ensuring your WAND registration is completed efficiently and that all necessary documentation aligns with Medsafe’s requirements for a seamless market entry.

Representation for Foreign Manufacturers in New Zealand

Authorized Representative

Companies without a local presence in New Zealand must appoint a local authorized representative or sponsor. The Sponsor handles WAND submissions and serves as the sole point of contact between the manufacturer and Medsafe for all product-related matters.

The Sponsor is also responsible for paying all product-related fees, including application fees, annual fees, and other regulatory costs. Like Australia’s regulatory framework, the Sponsor in New Zealand is accountable for product safety monitoring throughout its lifecycle.

Many Sponsors offer combined representation for Australian and New Zealand markets, simplifying regulatory processes for manufacturers targeting both regions.

Work with Qserve to ensure seamless representation and compliance in New Zealand.

Harmonization Between Australia and New Zealand

Simplified Market Access

Australia and New Zealand have established the Trans-Tasman Mutual Recognition Arrangement (TTMRA), allowing medical devices legally approved in one country to be recognized and sold in the other without undergoing additional regulatory procedures. This harmonization simplifies market access for manufacturers targeting both markets, reducing regulatory barriers and saving time.

However, it’s important to note that the TTMRA applies only to specific categories of medical devices. To benefit from mutual recognition, manufacturers must meet the specific conditions and requirements outlined in the agreement.

The regulatory authorities, TGA in Australia and Medsafe in New Zealand, provide clear guidelines and processes to support the mutual recognition of medical devices under the TTMRA.

Leverage this harmonized framework to streamline your market entry into Australia and New Zealand with Qserve’s expert guidance.