Exemptions from Medical Device Notification in New Zealand

1. Legal Basis and Purpose

Under section 4 of the Medicines (Database for Medical Devices) Regulations 2005, certain medical devices are exempt from the requirement to notify details to the Web Assisted Notification of Devices (WAND) database before supply in New Zealand. These exemptions apply to low-risk or specific-use devices where full notification is not considered necessary to protect public health, while general obligations under the Medicines Act 1981 (e.g., safety, quality, and performance) still apply. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-8MDExempt.asp

The exemptions aim to reduce regulatory burden for minimal-risk products without compromising safety. Sponsors must ensure exempted devices comply with essential principles of safety and performance, labelling requirements, and post-market vigilance obligations. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-8MDExempt.asp

2. Categories of Exempt Devices

The regulations provide exemptions in the following main categories:

• Custom-made devices: Devices specifically made for a named patient or healthcare professional based on their written prescription or order, intended for the sole use of that individual. These must not be mass-produced and are exempt from WAND notification. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-8MDExempt.asp

• Devices for clinical investigation/performance evaluation: Devices intended solely for use in clinical investigations or performance evaluation studies, provided they are not placed on the market for general supply and meet specific conditions (e.g., ethics approval where required). Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-8MDExempt.asp

• Low-risk devices supplied in limited circumstances: Certain Class I non-IVD devices or Class 1 IVD devices that are supplied in small quantities or for specific purposes may qualify for exemption if they meet defined criteria (e.g., not intended for widespread distribution). Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-8MDExempt.asp

• Other specific exemptions: Include devices supplied solely for export, devices used only within a healthcare facility for in-house purposes without commercial supply, and certain heritage or antique devices not intended for clinical use. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-8MDExempt.asp

3. Conditions and Responsibilities for Exempt Devices

Even when exempt from WAND notification, sponsors/manufacturers must:

• Ensure the device complies with the essential principles of safety and performance.
• Provide appropriate labelling and instructions for use in English.
• Maintain records of design, manufacture, and distribution.
• Report adverse events, field safety corrective actions, and cooperate with Medsafe investigations.
• Not make prohibited therapeutic claims in advertising or promotion.

Custom-made devices must be accompanied by a written statement from the manufacturer confirming compliance with essential principles and detailing the custom nature of the device. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-8MDExempt.asp

4. Borderline Cases and Advice

For devices that may fall on the border of exemption (e.g., limited production runs or devices modified for specific patients), sponsors are advised to contact Medsafe for clarification before supply. Misclassification or inappropriate reliance on exemptions can result in enforcement action. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-8MDExempt.asp

5. Additional Notes

The exemptions do not apply to devices that are otherwise classified as higher risk or intended for general commercial supply. Medsafe maintains oversight through post-market surveillance, and sponsors remain liable for any safety issues. The guidance aligns with international practices for low-risk/custom devices while ensuring public health protection. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-8MDExempt.asp

This framework balances regulatory oversight with practical access to specialized or minimal-risk medical devices in New Zealand. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/3-8MDExempt.asp