New Zealand medical device regulations

Regulations establishing the statutory notification database for medical devices supplied in New Zealand (administered by Medsafe as the WAND database). Official reprint as at 7 August 2020, made under section 105 of the Medicines Act 1981: regulations 1-15 cover the database, sponsor information and declaration duties, prohibited statements, and offences, with Schedule 1 exempt devices and the Schedule 2 risk-classification rules (clauses 1-22) carried as citeable clause anchors.

Parent statute for the New Zealand medical-device regime. Official reprint as at 10 July 2026 (1981 No 118, assent 23 October 1981): Parts 1-6 with sections 1-115 as citeable anchors, including the section 3A medical-device definition, related-product controls, and the section 105 regulation-making power under which the 2003 device-database regulations were made. Schedules 1AA (transitional), 1, 2 (repeals), and 3 (incorporation by reference) are carried as annex anchors.

Spent repealing statute that defines why the Medicines Act 1981 remains New Zealand’s controlling therapeutic-products law: assented 17 December 2024, in force the next day, and repealed itself at the close of 15 January 2025 (section 10). Section 3 repeals the Therapeutic Products Act 2023 (2023 No 37) — the never-commenced statute that would have replaced the Medicines Act regime for medicines, medical devices, and natural health products — while Part 1’s remaining sections undo its consequential Food Act 2014 and Dietary Supplements Regulations 1985 amendments. Official reprint as at 15 January 2025 (the final day the Act existed); sections 1-10 and Parts 1-2 carried as citeable anchors.

Medsafe overview of the legislation governing medical devices in New Zealand: one section per instrument — the Medicines Act 1981, Medicines Regulations 1984, Medicines (Database of Medical Devices) Regulations 2003, Contraception Sterilisation and Abortion Act 1977, HSNO Act 1996, Radiation Protection Act 1965, Human Tissue Act 2008, Health (Needles and Syringes) Regulations 1998, pressure-equipment PECPR regulations, and the Radiocommunications Act 1989 — each summarising what the instrument controls for devices. Page revised 1 July 2014 per its own stamp; ingested from the exact official HTML with the ten instrument sections carrying stable sec-1..sec-10 anchors.

Medsafe explainer of what the Web Assisted Notification of Devices (WAND) database is and is not: WAND is explicitly NOT an approval system, its statutory purpose under the 2003 Regulations, how Medsafe uses notified information, and the charges associated with the database. Page revised 10 May 2011 per its own stamp; ingested from the exact official HTML with sec-1..sec-4 anchors.

Medsafe guidance walking through the sponsor duties of the Medicines (Database of Medical Devices) Regulations 2003 regulation by regulation: Reg. 5 information required in the database, Reg. 6 information to be supplied by the sponsor, Reg. 7 declaration, Reg. 8 updated information, Reg. 9 arrangements to ensure compliance, Reg. 10 prohibited statements (no implication of Ministry endorsement from notification), and Reg. 14 offences. Page revised 10 May 2011 per its own stamp; ingested from the exact official HTML with sec-1..sec-7 anchors keyed to the printed regulation numbers.

Medsafe guidance on the New Zealand definitions that determine whether a product is regulated as a medical device or a medicine: therapeutic purpose (with understanding and claiming sub-sections quoting the Medicines Act definition), medicine, medical device, sponsor (quoting the Regulation 3 legal definition), and medical device manufacturer. Page revised 15 January 2015 per its own stamp; ingested from the exact official HTML with sec-1..sec-7 anchors; legal sub-headings stay body text inside their sections.

Medsafe explainer of the three-tier device risk-classification system (Classes I/II/III) applied through the 22 classification rules of Schedule 2 to the Medicines (Database of Medical Devices) Regulations 2003: explanation of the risk classes, the rules of risk classification, and how to apply the rules. The companion classification rules themselves are carried by the corpus Regulations 2003 extract (schedule-2 clause anchors). Page revised 10 May 2011 per its own stamp; ingested from the exact official HTML with sec-1..sec-3 anchors.

Medsafe guidance on devices exempt from WAND notification: the definition of an exempt device, what Schedule 1 of the 2003 Regulations exempts (with Medsafe’s interpretation section), the separate IVD exemption regime under the Exemption Notice, and how risk classification and GMDN codes apply to exempt IVDs. Page revised 1 July 2014 per its own stamp; ingested from the exact official HTML with sec-1..sec-6 anchors.

Medsafe guidance on the regulatory status of in-vitro diagnostic devices in New Zealand: IVDs are not medicines, voluntary notification to the WAND database, the IVD exemption from WAND under the Exemption Medical Devices (In Vitro Diagnostic Devices) Notice (No. 1) 2005, and conducting recalls and corrective actions for IVDs. Page revised 10 July 2014 per its own stamp; ingested from the exact official HTML with sec-1..sec-5 anchors.

Medsafe guidance on advertising medical devices in New Zealand: the definition of advertising, the controlling legislation (Medicines Act 1981 sections 20 and 20A therapeutic-purpose advertising restrictions and the prohibited-statement rule in Regulation 10 of the 2003 Regulations), claiming a therapeutic purpose, and Medsafe pre-vetting services for advertisements. Page revised 10 May 2011 per its own stamp; ingested from the exact official HTML with sec-1..sec-4 anchors.

Medsafe guidance on conducting recall and non-recall actions for medical devices: responsibilities of sponsors, recall preparation and planning, advising Medsafe, drafting a recall action notice, conducting the recall action, reporting to Medsafe, and closure of a recall action. The page <title> reads "Recalls and Corrective Actions" while the document heading reads "Recall and Non-Recall Actions"; both names refer to this same page. Page revised 14 January 2016 per its own stamp; ingested from the exact official HTML with sec-1..sec-7 anchors.

Medsafe guidance on reporting problems with medical devices: the changed incident-reporting process, reporting issues associated with medical devices, information for consumers, recommended reporting timelines (initial report as soon as possible and within 10 calendar days for death or serious injury, longer windows for minor injury and other events), why report a suspected adverse event, non-reportable events, the Medsafe process, and definitions. Page revised 19 March 2020 per its own stamp — the most recently revised page of this family; ingested from the exact official HTML with sec-1..sec-8 anchors.

Medsafe guidance on conducting medical-device clinical trials in New Zealand: the definition of a clinical trial, Ethics Committee approval, interaction with Medsafe, adverse event reporting during clinical trials, and the clinical trial guidance documents. Page revised 10 May 2011 per its own stamp; ingested from the exact official HTML with sec-1..sec-5 anchors.

Two-part Medsafe guidance page: Part 1 labelling of medical devices (minimum requirements from the Medicines Regulations 1984, clinical-trial labelling, and the GHTF/SG1/N43:2005 international labelling guidelines Medsafe recommends applying) and Part 2 instructions for use, including Medsafe’s guidance permitting electronic IFU provided the sponsor can supply a hardcopy on request. The official page <title> misspells "Instructions" as "Instrictions"; the canonical title records the corrected form. The page publishes no Revised stamp. Ingested from the exact official HTML with part-1/part-2 chapter anchors and sec-1..sec-6 section anchors.