Glossary of key terms
AIMD — Active Implantable Medical Device. A device powered by an electrical energy source that is intended to be totally or partially introduced into the human body by surgical or medical intervention and intended to remain after the procedure. Examples: pacemakers, cochlear implants, implantable defibrillators.
Adverse event — An incident involving a medical device that has led to, or could have led to, serious injury or death of a patient, user, or other person.
Conformity evidence — Documentation demonstrating that a device meets applicable safety and performance requirements. In New Zealand, this typically takes the form of a CE certificate, TGA ARTG listing, FDA clearance, or Health Canada licence — or equivalent technical documentation.
Custom-made device — A device specifically made in accordance with a written prescription for a named individual patient by a person professionally qualified to do so. Custom-made devices have different notification obligations to standard devices.
FSCA — Field Safety Corrective Action. An action taken to reduce a risk of death or serious injury associated with a device already placed on the market. FSCAs include recalls, field corrections, and updated instructions.
FSN — Field Safety Notice. A communication sent to customers, distributors, and users about an FSCA.
GHTF — Global Harmonization Task Force. An international body (now succeeded by IMDRF) that developed foundational guidance documents on medical device regulation. Medsafe's labelling and conformity assessment expectations reference GHTF guidance.
GMDN — Global Medical Device Nomenclature. An international system of generic names for medical devices, maintained by the GMDN Agency. WAND notification requires a GMDN code for each device.
IMDRF — International Medical Device Regulators Forum. The successor to GHTF, coordinating international regulatory harmonisation. Medsafe participates in IMDRF work.
IVD — In Vitro Diagnostic device. A device intended for the examination of specimens derived from the human body (e.g., blood glucose meters, pregnancy tests, COVID-19 rapid tests). IVDs are exempt from mandatory WAND notification in New Zealand.
Medsafe — New Zealand Medicines and Medical Devices Safety Authority. The regulatory authority for medicines and medical devices within the Ministry of Health.
Medicines Act 1981 — The primary legislation governing medical devices in New Zealand.
Medical Products Bill — The proposed new legislation to replace the Medicines Act 1981 with a modern, risk-proportionate framework for medicines and medical devices.
Post-market surveillance (PMS) — Systematic collection and analysis of data about a device's performance on the market, used to identify safety signals and drive improvements.
SaMD — Software as a Medical Device. Software that is intended to be used for medical purposes without being part of a hardware medical device.
Sponsor — The New Zealand-based entity (company or individual) that takes legal responsibility for a medical device under the Medicines Act 1981. Foreign manufacturers must appoint a Sponsor to supply devices in NZ.
Therapeutic Products Act 2023 (TPA) — Legislation that was passed in 2023 but repealed in 2024 before taking effect, following a change of government. Its provisions inform the current Medical Products Bill being developed.
TTMRA — Trans-Tasman Mutual Recognition Arrangement. An agreement between Australia and New Zealand allowing goods lawfully supplied in one country to generally be supplied in the other without additional regulatory requirements.
WAND — Web Assisted Notification of Devices. Medsafe's online database where sponsors must notify medical devices before supply. WAND is not publicly accessible — only sponsors and Medsafe staff can view entries.