New Zealand entered a new regulatory era with the introduction of the Therapeutic Products Act (TPA), a framework that reshapes how medical devices enter, stay, and perform in the market. The TPA replaces the old Medicines Act and establishes structured oversight across device lifecycle stages. The system strengthens public health protection, improves traceability, and creates operational clarity for sponsors and manufacturers targeting the New Zealand market. This shift significantly updates New Zealand medical device regulation under the TPA, bringing stronger oversight for manufacturers and sponsors.
TPA Medical Device Regulation Framework in New Zealand
The TPA establishes a unified law for medicines, medical devices, and related products. It defines clear roles for Medsafe, the regulator responsible for administering the Act. Medsafe evaluates sponsor responsibilities, authorisation pathways, and post-market obligations through rules that align with global regulatory principles. The TPA introduces precise definitions for devices, accessories, intended purpose, and classification boundaries. These definitions form the core of regulatory decision-making and remove interpretational ambiguity that existed earlier.
New Zealand Medical Device Classification Framework
New Zealand now uses a risk-based classification system that aligns with the IMDRF model. The TPA divides medical devices into:
- Class I (lowest risk)
- Class IIa
- Class IIb
- Class III (highest risk)
- IVD Classes A–D for in vitro diagnostics
Classification decisions depend on the device’s intended purpose, invasiveness, duration of contact, and technology type. A sponsor must classify the device correctly before any authorisation step. Errors at this stage cause delays, therefore manufacturers must conduct technical mapping with precision.
Authorisation Pathways for Medical Devices
The TPA introduces the requirement for new product market authorisation. No device can be supplied in New Zealand without approval. The main pathways include:
- Full Application
This pathway applies when a device has no recognised approvals or when the technology introduces novel mechanisms. Sponsors submit complete technical documentation covering design, risk analysis, performance, clinical evidence, labelling, and manufacturing controls.
- Approval Based on Comparable Overseas Regulators (CORs)
The TPA allows recognition of assessments from trusted authorities. The list typically includes the TGA, FDA, EU notified bodies, and Health Canada. Sponsors must demonstrate alignment between the approved version abroad and the version for New Zealand. This pathway shortens assessment time but still requires core evidence components.
- IVD-Specific Pathways
IVDs follow classification-driven requirements. High-risk infectious disease tests and blood-screening assays fall under intensive review. Lower-risk assays follow streamlined notifications with targeted evidence checks.
Sponsor Obligations Under the TPA
Sponsors carry legal accountability for the device in New Zealand. The TPA outlines detailed requirements:
- Establish and maintain a New Zealand-based responsible person
- Maintain documented quality and supply chain controls
- Ensure device traceability through UDI and supply documentation
- Submit annual reporting information for a subset of devices
- Notify Medsafe of any significant product changes
- Ensure correct advertising practices aligned with TPA rules
Sponsor responsibilities apply throughout the device lifecycle, including importation, supply, and post-market surveillance.
Post-Market Surveillance and Vigilance Expectations
The TPA strengthens ongoing oversight. Sponsors must operate a structured vigilance system that collects, analyses, and reports safety information. Key obligations include:
- Adverse event reporting within defined timelines
- Complaint handling systems with documented investigations
- Corrective and preventive action (CAPA) processes
- Periodic safety reports for higher-risk devices
- Risk-benefit reassessment when new data signals potential concerns
Medsafe now holds stronger authority to conduct investigations, request documentation, audit facilities, and issue recalls or conditions of supply.
Labelling and UDI Requirements
The TPA emphasises transparency for users and healthcare providers. Labelling must include:
- Intended purpose
- Correct usage instructions
- Warnings and precaution statements
- Traceability information
- UDI for specified classes
Electronic labelling is permissible under defined conditions. Sponsors must ensure that labelling aligns with the approved version of the device.
Pathway for Software as a Medical Device (SaMD)
The TPA provides clear regulatory expectations for SaMD. Sponsors must demonstrate software validation, cybersecurity controls, real-world performance data, and update management systems. Device classification depends on the clinical purpose of the software. Diagnostics, disease prediction tools, and treatment-support algorithms generally fall under higher classes. Wellness and lifestyle applications fall outside the scope when they avoid clinical claims.
Transition Period and Industry Readiness
New Zealand has set transition timelines that allow sponsors and manufacturers to adjust to the TPA framework. Existing devices must shift to the new authorisation model within the designated transition window. Sponsors must begin technical documentation reviews, classification checks, and evidence gap analyses early. A structured internal readiness programme reduces delays and ensures business continuity.
How DDReg Supports Manufacturers Targeting New Zealand
DDReg enables smooth market entry for companies preparing for New Zealand’s TPA requirements. Our regulatory network supports classification strategy, documentation review, COR-based submissions, QMS alignment, PMS system setup, and sponsor guidance. Our team ensures clear technical positioning and accurate regulatory communication with Medsafe.
Conclusion
New Zealand’s regulatory affairs environment has moved into a modernised structure through the Therapeutic Products Act. The system introduces lifecycle-focused oversight, global alignment, and precise sponsor obligations. Manufacturers with strong documentation systems and proactive compliance planning achieve faster authorisation and sustained supply across the New Zealand market.
Read more from our experts: EU Confirms EUDAMED Functionality With May 2026 Deadline Set