Conducting Clinical Trials with Medical Devices in New Zealand

1. Regulatory Overview

Clinical trials involving medical devices in New Zealand do not require formal approval from Medsafe. https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp The Medicines Act 1981 does not regulate clinical trials of medical devices, unlike medicines which require approval under section 30. https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp

However, all clinical trials must receive ethical approval from an accredited ethics committee before commencing. https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp Sponsors and investigators are expected to follow good clinical practice (GCP) principles, including those outlined in ISO 14155 (Clinical investigation of medical devices for human subjects — Good clinical practice). https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp

2. Ethical Review Requirements

Every clinical trial involving medical devices must be reviewed and approved by an ethics committee accredited by the Health Research Council Ethics Committee Accreditation Programme or a comparable overseas body. https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp

The ethics committee assesses the trial protocol, participant information sheets, consent forms, and risk-benefit considerations. https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp Trials involving vulnerable populations or higher-risk devices may require additional scrutiny. https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp

3. Good Clinical Practice and Standards

Sponsors and investigators should conduct trials in accordance with ISO 14155:2020 or equivalent GCP guidelines to ensure participant safety, data integrity, and scientific validity. https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp

Key GCP elements include informed consent, risk assessment, adverse event monitoring, data management, and trial oversight. https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp For higher-risk devices, additional safeguards such as independent data monitoring committees may be appropriate. https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp

4. Sponsor Responsibilities

The sponsor is responsible for:

• Ensuring ethical approval is obtained before trial commencement
• Implementing appropriate safety monitoring and adverse event reporting systems
• Maintaining accurate trial records and data
• Reporting serious adverse events to the ethics committee and Medsafe where relevant
• Complying with ISO 14155 or equivalent standards

Medsafe may investigate safety issues or non-compliance under section 38 of the Medicines Act 1981. https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp

5. Adverse Event Reporting

All serious adverse events must be reported promptly to the ethics committee. https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp Sponsors should also report to Medsafe any events indicating a safety concern with the device, particularly if the device is already on the market. https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp

6. Additional Considerations

Trials involving investigational devices that are not yet approved for supply may require special labelling (e.g., "For investigational use only"). https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp

For combination products (device + medicine), additional requirements under the medicines regulations may apply. https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp

Medsafe encourages early consultation for complex trials or those involving high-risk devices. https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp

This framework supports ethical and scientifically sound clinical research while maintaining patient safety without imposing unnecessary regulatory barriers. https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp