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Introduction

Medsafe does not regulate or approve clinical trials for medical devices in New Zealand, but does request that it be informed of such trials. Clinical trials are conducted to determine the suitability of a product for a specific therapeutic purpose. This can be the testing of a pre-production product or the use of a product for a new indication or application. Medical device clinical trials require ethics committee approval and are expected to be conducted in accordance with international best practice guidelines.

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Definition of a clinical trial

A clinical trial is the scientific study of a new device design, application, or treatment that is conducted to collect data on the safety and efficacy of the intervention. Such trials are usually conducted before a device is released by the manufacturer, but they may also be conducted using an established device in an experimental application. The evaluation of a device for the purposes of making a purchasing decision is a commercial evaluation, and not a clinical trial.

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Ethics Committee approval

Medical device clinical trials require ethics committee approval prior to the clinical trial being conducted. The New Zealand Health and Disability Ethics Committee's primary role is to safeguard the rights, health and wellbeing of consumers and research participants by providing independent ethical review of proposed research.

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Interaction with Medsafe

Institutions planning on conducting medical device clinical trials in New Zealand are requested to inform Medsafe of their plans before the commencement of the trial. Medical devices imported into, or manufactured in, New Zealand for the purposes of clinical trials are exempt from notification to the WAND database under Schedule 1(h) of the Medicines (Database of Medical Devices) Regulations 2003.

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Adverse event reporting during clinical trials

Medsafe operates a voluntary scheme for medical device adverse event reporting that sponsors, users, healthcare professionals, and carers can submit reports to. Medsafe recommends this scheme be used to report serious, unexpected, adverse events that occur during the clinical trial.

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Clinical trial guidance documents

Medsafe recommends organisations planning to conduct medical device clinical trials in New Zealand familiarise themselves with the following guidance documents, and ensure compliance with such guidance. Guideline on the Regulation of Therapeutic Products in New Zealand: Part 11, Clinical Trials - regulatory approval and good clinical practice requirements This is a Medsafe guideline and is available for download from the Medsafe website. ISO 14155:2011 Clinical Investigation of Medical Devices for Human Subjects - Good Clinical Practice ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.