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Medsafe · structured requirements

🇳🇿 New Zealand IVD regulatory data

Explore the IVD requirements currently available for New Zealand, organized by topic and linked to official sources.

9 facts6 dimensions7 official sourceslatest verification 2026-09-15

Changes after registration

Explore questions and sources →

Common questions about changing a registered IVD in New Zealand. Each question separates published rules from details still awaiting verification.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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IVD scope and notification exemption

device-definition.ivd-scope
Fact-level verified

IVDs are categorised as medical devices under the Medicines Act 1981, but are currently exempt from mandatory notification to the WAND database; they may be voluntarily notified, and suppliers are expected to notify Medsafe of safety issues or corrective actions.

Conditions
  • Exemption from notification does not remove other Medicines Act obligations.

Effective from 2004-01-01

Reverse of the baseline hint (general devices mandatory, IVDs exempt); exemption basis is the Gazette declaration under Schedule 1(i).

Fees

What regulator fee applies to this class, route, event, and date?

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Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Recall Code and Medsafe consultation

recall.recall-code
Fact-level verified

Recalls and other corrective actions should be conducted in consultation with Medsafe according to the New Zealand Medicines and Medical Devices Recall Code (latest edition in effect from 1 December 2015). Sponsors should discuss the issue with Medsafe before initiating any recall or non-recall action, provide progress reports, and submit a final closure report; Medsafe should also be advised of post-market actions for safety reasons on exempt devices.

Conditions
  • Applies to all devices including WAND-exempt devices.

Effective from 2015-12-01

No numeric regulatory deadlines for recall execution appear on the page.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Schedule 1 exempt devices

registration.exempt-devices
Fact-level verified

Exempt from WAND notification (Schedule 1): devices that are also medicines; custom devices made to a registered health professional's design specification for a particular patient; devices supplied to a practitioner for a particular patient; devices held by NZ Customs pending export; IVDs used only within one laboratory; lab-made tests supplied to another laboratory; personal-use imports; devices imported for clinical trials; and classes declared exempt by Director-General Gazette notice.

Conditions
  • An exempt device must still comply with all other requirements of the Medicines Act and its associated Regulations.

Medsafe guidance version at res-nz-exempt.

IVD exemption Gazette declaration

registration.ivd-exemption-gazette
Fact-level verified

The Director-General declared, under paragraph (i) of Schedule 1 and by notice in the New Zealand Gazette, that 'any diagnostic device that is commonly known as an in vitro diagnostic device' is an exempt class of medical device, effective 1 January 2004 — removing the mandatory WAND notification duty for IVDs.

Conditions
  • Signed by Dr Karen Poutasi, Director-General of Health, 12 December 2003; Gazette 18 December 2003.

Effective from 2004-01-01

Market-access route

registration.market-access-route
Fact-level verified
Route

notification

Premarket Approval

No

Description

No premarket approval or assessment system exists for medical devices under the Medicines Act 1981. Sponsors of non-exempt devices must notify device information to the free WAND database within 30 working days of becoming sponsor. IVDs are exempt (voluntary notification only). Notification does not mean or imply the device has been assessed by Medsafe.

Conditions
  • Non-exempt devices
  • IVDs exempt since 1 January 2004
  • Notification is not an approval or endorsement.

Confirmed with a precise locator; 30-working-day duty is reg 6 (res-nz-dbregs).

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

New Zealand approvals and evidence in other markets (4 records)

BahrainSaudi Arabia · US FDA · UK MHRA · Australia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · Ireland · Denmark · New Zealand · France · Netherlands · Belgium

Prior approval / evidence record

Free Sale Certificate may be issued by the country of origin or by a reference country

reliance.free-sale-certificate-origin-or-reference-country
Fact-level verified
Statement

At renewal, Bahrain requires a Free Sale Certificate (FSC) or Certificate to Foreign Government issued by the regulatory authority of the country of origin or of a reference country (Registration Guideline 9.1, section 10 item 4). The guideline's glossary (item 14) defines reference countries as Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland and Belgium, so a certificate from one of those authorities substitutes for an origin-country free-sale certificate. A Free Sale Certificate is also required on manufacturer acquisition (section 12).

Source Approval

Free Sale Certificate or Certificate to Foreign Government from the country of origin or from a reference country (Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium)

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The classification guideline separately accepts a Free Sale Certificate OR Registration Certificate from one of the reference countries as a classification requirement
  • The reference-country list in the registration guideline glossary includes Canada, Denmark, the Netherlands ('Holland') and New Zealand, which are not in the Article (7) bis list of Resolution No. (69) of 2024, and omits Germany
  • Free Sale Certificate is also required on manufacturer acquisition (Section 12)

Verbatim source passages: "Free Sale Certificate (FSC) or Certificate to foreign government issued by the regulatory authority of the country of origin or a reference country." and "Reference countries: Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium."

BahrainSaudi Arabia · US FDA · UK MHRA · Australia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · Ireland · Denmark · New Zealand · France · Netherlands · Belgium

Prior approval / evidence record

Classification of a product as a medical device may be evidenced by a registration certificate from a reference country

reliance.reference-country-certificate-for-classification
Fact-level verified
Statement

To obtain an NHRA classification letter, the applicant must supply a Free Sale Certificate or Registration Certificate issued by the competent authority of the country of origin or by one of the reference countries listed in the classification guideline (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium), together with a recognised quality assurance certificate such as ISO 13485, CE mark or FDA.

Source Approval

Registration certificate or Free Sale Certificate from SFDA (Saudi Arabia), US FDA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland or Belgium

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

classification

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • A classification letter is a separate, fee-bearing NHRA service that precedes importation and registration
  • The reference-country list here is broader than the Article (7) bis list in Resolution No. (69) of 2024 and omits Germany and includes Canada, Denmark, the Netherlands and New Zealand
  • For class I products without CE marking a manufacturer's Declaration of Conformity may be provided

Verbatim source passage: "1. Free Sale Certificate OR Registration Certificate issued from competent authority in country of origin classifies the product as a medical device. 2. Free Sale Certificate OR Registration Certificate issued from one of the following reference countries: (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, Newzland, France, and Holland, Belgium.)."

IsraelUS FDA · UK MHRA · Germany · France · Italy · Spain · Netherlands · Belgium · Ireland · Denmark · Sweden · Finland · Norway · Iceland · Greece · Portugal · Austria · Swissmedic · Australia TGA · Health Canada · New Zealand

Regulatory reference

Recognized-state registration route

reliance.recognized-country-route
Fact-level verified

A device registered, or approved for marketing and actually marketed, in a 'recognized state' (מדינה מוכרת) is registered in the Israeli register for a period not exceeding the period it may be marketed in that state, capped at 5 years from Israeli registration. Recognized states are listed in the First Addendum to the law — 21 states including the US, UK, Germany, France, Italy, Spain, the Netherlands, Belgium, Ireland, Denmark, Sweden, Finland, Norway, Iceland, Greece, Portugal, Austria, Switzerland, Australia, Canada and New Zealand (no single 'EU' entry: member states are listed individually).

Conditions
  • Device must be registered or permitted for marketing and actually marketed in the recognized state.

First Addendum list per the official Sefer HaChukim text of the law held from gov.il.

ParaguayBrazil ANVISA · US FDA · Health Canada · Austria · Belgium · Denmark · Finland · France · Germany · Hungary · Ireland · Italy · Netherlands · New Zealand · Norway · Spain · Sweden · Japan MHLW / PMDA · UK MHRA · Swissmedic · Australia TGA · WHO

Prior approval / evidence record

IVD Annex I reference-country list drives the 30/45/120-business-day clocks

reliance.ivd-anexo-i-reference-country-list
Fact-level verified
Statement

For IVDs, DINAVISA decides within 30 business days for products manufactured nationally or in a country of Annex I, within 45 business days for products manufactured outside Annex I but registered and commercialised in an Annex I country (which must additionally file the foreign registration certificate and free-sale certificate), and within 120 business days for other imports. Annex I names high-surveillance and adequate-surveillance authorities and the full MERCOSUR members; the United States and Japan are on it and Korea is not.

Source Approval

Sanitary registration and free-sale certificate in force in an Annex I country — high-surveillance authorities (Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden, Switzerland) or adequate-surveillance authorities (Australia, Chile, Cuba, Finland, Hungary, Ireland, Luxembourg, Mexico, Norway, New Zealand); Annex I also lists full MERCOSUR members (Argentina, Brazil, Paraguay, Uruguay) and PAHO/WHO reference authorities

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The Annex I list derives from Ley N° 3283/2007 Art. 11 (high and adequate sanitary surveillance).
  • A product made outside Annex I is admitted on a 45-day clock only if it is registered and commercialised in an Annex I country.
  • Korea (MFDS) does not appear in Annex I, so a Korean-only IVD authorisation does not by itself reach the 30/45-day clocks.
  • A Paraguayan sanitary registration is still required in every case.

Source language: Spanish. Translation of the quoted Annex I heading and entries: 'Countries with High and Adequate Sanitary Surveillance Authorities (Law 3283/07 Article 11)' / 'Countries with high sanitary surveillance regulatory authorities: Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden and Switzerland.' / 'Full MERCOSUR members: Argentina, Brazil, Paraguay and Uruguay.' The excerpt is taken from the resolution's own Annex I; Art. 6 supplies the 30- and 45-business-day clocks.

Prior approvals and evidence for New Zealand (4 records)

New ZealandUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

Yes

Benefit

Same position as a CE certificate: useful evidence for the sponsor, irrelevant to the notification itself.

Timeline Savings

None — there is no review period to shorten

Medicines (Database of Medical Devices) Regulations 2003 — WAND notification dutiesMedsafe — Regulatory Requirements for Sponsors: reg 6 requires notification within 30 working days of becoming the sponsor (read as running from the date the device first arrives in New Zealand), reg 8 requires corrections within 10 working days, reg 10 forbids treating notification as endorsement, and reg 14 makes contravention of regs 6, 8, 9 or 10 an offence fined up to $500Therapeutic Products Act Repeal Act 2024 (2024 No 55) — repealed the Therapeutic Products Act 2023 on 18 December 2024 before its 1 September 2026 commencement, leaving devices under the Medicines Act 1981 and the WAND regulations

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

New ZealandSource authority not specified

Regulatory reference

No foreign product approval needed

reliance.no-foreign-approval-required
Fact-level verified

No foreign regulatory approval is required or assessed: there is no mandatory requirement for medical devices to be approved by any medical device regulator prior to being supplied in New Zealand, and WAND notification does not mean or imply that a device has been assessed by Medsafe (quality, safety, efficacy, or performance).

Conditions
  • Devices must still meet Medicines Act standards, labelling and advertising rules and post-market obligations.

Confirms the baseline reliance edge: notification_without_premarket_approval, local WAND application required, no target decision retained.

New ZealandNMPA

Regulatory reference

China NMPA approval: no recognition regime

reliance.china-nmpa-no-recognition-route
Pending verification
Statement

New Zealand has no pre-market approval system for medical devices: there is no mandatory requirement for a device to be approved by any regulator before supply, and WAND notification does not imply any Medsafe assessment. A China NMPA certificate therefore has no regulatory role; the sponsor simply notifies the device to WAND and meets Medicines Act, labelling, advertising and post-market obligations.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

new-zealand

China Classes In Scope

All classes

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Mandatory WAND notification by importers/exporters/manufacturers
  • No foreign approval is required or assessed
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2004-01-01

Source passage: There is no approval system for medical devices under the Medicines Act 1981. There is no mandatory requirement for medical devices to be approved by any medical device regulator prior to being supplied in New Zealand. Notification to the WAND database does not mean or imply that a medical device has been assessed by Medsafe in terms of quality, safety, efficacy, or performance.

New ZealandEU conformity assessment

Prior approval / evidence record

CE Mark (EU MDR)

Authority

CE Mark (EU MDR)

Accepted

Yes

Benefit

Neither required nor rewarded. WAND is a sponsor notification rather than an assessment: Medsafe does not review the device before it goes on the database, so there is no decision for a foreign approval to influence. The certificate matters as evidence the sponsor holds behind the notification.

Timeline Savings

None — there is no review period to shorten

Medicines (Database of Medical Devices) Regulations 2003 — WAND notification dutiesMedsafe — Regulatory Requirements for Sponsors: reg 6 requires notification within 30 working days of becoming the sponsor (read as running from the date the device first arrives in New Zealand), reg 8 requires corrections within 10 working days, reg 10 forbids treating notification as endorsement, and reg 14 makes contravention of regs 6, 8, 9 or 10 an offence fined up to $500Therapeutic Products Act Repeal Act 2024 (2024 No 55) — repealed the Therapeutic Products Act 2023 on 18 December 2024 before its 1 September 2026 commencement, leaving devices under the Medicines Act 1981 and the WAND regulations

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

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Reportable events and reporters

vigilance.who-and-what-reportable
Fact-level verified

Anyone can report an issue associated with a medical device to Medsafe at devices@health.govt.nz; patients, caregivers, healthcare professionals and suppliers are encouraged to report under the voluntary scheme. Non-reportable events include: deficiencies found before use, patient-condition root causes, service/shelf-life issues, correct fail-safe (malfunction protection) operation, events already described in a recall/alert, improper use or maintenance, and expected foreseeable events fully described in the IFU.

Conditions
  • Reporting is voluntary; forms exist for industry, health professionals and consumers.

Medsafe no longer requires initial reports of minor injury events, only final reports.

Related structured datasets

Classification systems · 0 records

No maintained record.

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open New Zealand registration →
Country

New Zealand

Jurisdiction Id

new-zealand

Country Code

NZ

Flag

🇳🇿

Regulator

Medsafe (Ministry of Health)

Regulator Abbrev

Medsafe

Region

asia-pacific

Tier

3

Risk Classification

4-class (I, IIa, IIb, III) — WAND notification-based system

Classes
  • Id

    wand-notification

    Class Name

    All devices (WAND notification)

    Risk Level

    low

    Pathway

    Notification to the Web Assisted Notification of Devices (WAND) database

    Official Timeline
    Min

    0

    Max

    0

    Unit

    days

    Realistic Timeline
    Min

    1

    Max

    2

    Unit

    months

    Notes
    • Zero regulator decision time, at every risk class. WAND is a database, not an approval: there is no pre-market assessment, no fee, and no certificate, and a completed notification is confirmed on submission once the sponsor signs the declaration under reg 7
    • The well-known 30 working days is a duty on the sponsor, not a review period. Reg 6 requires the device to be notified within 30 working days of becoming its sponsor, which Medsafe reads as running from the date the device first arrives in New Zealand — so supply may lawfully begin before the notification is filed
    • Reg 8 requires notified information to be corrected within 10 working days of it ceasing to be correct, which is also how a change of sponsor is handled: the outgoing sponsor marks entries obsolete and the incoming one re-notifies
    • Reg 10 forbids any statement implying that notification is an endorsement of safety or suitability, and reg 14 makes contravention of regs 6, 8, 9 or 10 an offence carrying a fine of up to $500
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

    Verification Status

    official-verified

    Official Source
    Title

    Medsafe — Regulatory Requirements for Sponsors: reg 6 requires notification within 30 working days of becoming the sponsor (read as running from the date the device first arrives in New Zealand), reg 8 requires corrections within 10 working days, reg 10 forbids treating notification as endorsement, and reg 14 makes contravention of regs 6, 8, 9 or 10 an offence fined up to $500

    Url

    https://www.medsafe.govt.nz/regulatory/devicesnew/3-6RegulatoryRequirements.asp

    Accessed Date

    2026-08-30

Key Requirements
  • New Zealand sponsor (local representative) responsible for the WAND notification
  • Devices must be sourced from a country with an approved regulatory regime (e.g., EU MDR, FDA TGA-equivalent) or meet alternate-entry rules
  • Reg 9 requires the sponsor to have procedures in place that ensure compliance with regs 5, 6 and 8 — the obligation is a standing one, not a single filing
  • The pre-market regime that would have replaced this never arrived. The Therapeutic Products Act 2023 would have introduced full device regulation on 1 September 2026, but it was repealed on 18 December 2024 before commencing, so devices remain under the Medicines Act 1981 and the WAND regulations while a Medical Products Bill is drafted
Prior Approvals
  • Authority

    CE Mark (EU MDR)

    Accepted

    Yes

    Benefit

    Neither required nor rewarded. WAND is a sponsor notification rather than an assessment: Medsafe does not review the device before it goes on the database, so there is no decision for a foreign approval to influence. The certificate matters as evidence the sponsor holds behind the notification.

    Timeline Savings

    None — there is no review period to shorten

  • Authority

    FDA 510(k)/PMA

    Accepted

    Yes

    Benefit

    Same position as a CE certificate: useful evidence for the sponsor, irrelevant to the notification itself.

    Timeline Savings

    None — there is no review period to shorten

Local Rep Required

Yes

Local Rep Name

New Zealand Sponsor

Mdsap Accepted

No

Mdsap Benefit

Not accepted

Registration Validity

Notification does not expire, but reg 8 requires corrections within 10 working days of any notified detail ceasing to be correct

Last Updated

2026-08-30

Verification Status

official-verified

Reviewed On

2026-08-30

Official Sources
  • Title

    Medicines (Database of Medical Devices) Regulations 2003 — WAND notification duties

    Url

    https://www.legislation.govt.nz/regulation/public/2003/0325/latest/whole.html

    Effective Date

    2003-12-15

    Accessed Date

    2026-08-30

  • Title

    Medsafe — Regulatory Requirements for Sponsors: reg 6 requires notification within 30 working days of becoming the sponsor (read as running from the date the device first arrives in New Zealand), reg 8 requires corrections within 10 working days, reg 10 forbids treating notification as endorsement, and reg 14 makes contravention of regs 6, 8, 9 or 10 an offence fined up to $500

    Url

    https://www.medsafe.govt.nz/regulatory/devicesnew/3-6RegulatoryRequirements.asp

    Accessed Date

    2026-08-30

  • Title

    Therapeutic Products Act Repeal Act 2024 (2024 No 55) — repealed the Therapeutic Products Act 2023 on 18 December 2024 before its 1 September 2026 commencement, leaving devices under the Medicines Act 1981 and the WAND regulations

    Url

    https://www.legislation.govt.nz/act/public/2023/0037/latest/whole.html

    Effective Date

    2024-12-18

    Accessed Date

    2026-08-30

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by Medsafe. Appoint a New Zealand Sponsor.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to Medsafe including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    Medsafe reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. Medsafe may issue questions.

    Duration

    0 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, Medsafe issues New Zealand market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open New Zealand fees →
Jurisdiction Id

new-zealand

Country

New Zealand

Country Code

NZ

Authority

Medsafe

Low Risk Local
Min

0

Max

0

Currency

NZD

Per Product

Yes

High Risk Local
Min

0

Max

0

Currency

NZD

Per Product

Yes

Details
  • Id

    wand-notification

    Item

    WAND database notification (all device classes)

    Currency

    NZD

    Amount Local

    0

    Amount Local Formatted

    NZD 0

    Frequency

    Per notification

    Notes

    Notification is free and there are no on-going fees; Medsafe states "There are no charges associated with the database."

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.medsafe.govt.nz/regulatory/wand.asp

    Source Title

    Medsafe WAND database: notification is free with no ongoing fees

    Verified On

    2026-08-25

Notes
  • This zero amount applies specifically to WAND database notification, for which Medsafe expressly states there are no charges.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    Medsafe WAND database: notification is free with no ongoing fees

    Url

    https://www.medsafe.govt.nz/regulatory/wand.asp

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open New Zealand certifications →
Slug

new-zealand

Market

New Zealand

Confidence

high

Schemes
  • Id

    electricity-act-compliance

    Name

    Electricity Act 1992 compliance

    Category

    General Electrical Components

    Status

    Mandatory If Feature

    Object

    Electrically Powered Device

    Note

    Medsafe other-legislation page still points electrically powered devices at the Electricity Act 1992 and its associated Energy Safety regulations. Schedule 4 of the Electricity (Safety) Regulations 2010 (declared medium/high-risk articles and the Regulation 83 SDoC) was not opened in this pass, so no claim is made that a given medical device is a declared article.

    Source Urls
    • https://www.medsafe.govt.nz/regulatory/devicesnew/2Legislation.asp
    Source Binding

    reviewed

  • Id

    radiation-safety-act-source-and-use-licence

    Name

    Radiation Safety Act 2016 source and use licences

    Category

    Ionizing Radiation

    Status

    Mandatory If Feature

    Object

    Irradiating Apparatus Or Radioactive Material

    Note

    The Radiation Protection Act 1965 is spent. Radiation Safety Act 2016 s 5 defines irradiating apparatus as electrical equipment that emits ionising radiation and a radiation source as radioactive material or an irradiating apparatus. Section 13 forbids, unless the Act or regulations provide otherwise, manufacturing, possessing, managing or controlling a radiation source without a source licence, using a radiation source without a use licence, and importing or exporting radioactive material without a consent. Section 17 is the source licence; s 15 lists the limited cases where a source licence is not required (including transport). Import of an X-ray generator is therefore a possession/control question under s 13(a), not the s 13(c) radioactive-material consent.

    Source Urls
    • https://www.legislation.govt.nz/act/public/2016/0006/latest/DLM6339547.html
    Source Binding

    candidate

  • Id

    radiocommunications-act-compliance

    Name

    Radiocommunications Act 1989 supplier declaration against the Radio Standards Notice

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Radio Device

    Note

    Radiocommunications Regulations (Radio Standards) Notice 2025 (Gazette 2025-go4751, in force 1 September 2025, revoking the 2023 notice) Table 1 puts Short Range Devices 9 kHz–40 GHz on AS/NZS 4268 at Level of Conformity A1, and Medical Implant Communication Systems in 402–406 MHz on EN 301 839 V2.1.1 at A1. RSM Step 4 requires a Supplier Declaration of Conformity under the Radiocommunications Act 1989 for every A1 product (and for all level 2, 3, A2 and A3 products). Products that complied with the 2023 notice on 1 September 2025 remain compliant under the 2025 notice (transitional provision on the Gazette page).

    Source Urls
    • https://gazette.govt.nz/notice/id/2025-go4751
    Source Binding

    candidate

  • Id

    pecpr-pressure-vessel-certification

    Name

    PECPR pressure-vessel certification

    Category

    General Electrical Components

    Status

    Mandatory If Feature

    Object

    Autoclave Or Pressure Vessel

    Note

    Autoclaves and pressure vessels must comply with the Pressure Equipment, Cranes and Passenger Ropeways (PECPR) Regulations 1999; condoms must meet standards under the Contraception, Sterilisation and Abortion Act 1977; the supplier bears responsibility for identifying all applicable legislation.

    Source Binding

    unresolved

  • Id

    regulation-62-performance-claims

    Name

    Regulation 62 physical-force performance claims

    Category

    Non Ionizing Radiation

    Status

    Evidence Only No Separate Certificate

    Object

    Device With Physical Force Claims

    Note

    Medicines Regulations 1984 reg 62: a medical device claimed to operate by inducing, concentrating, directing or producing magnetic, galvanic, electrical, electromagnetic, radiation or vibratory forces must not be sold unless the claimed properties are quantitatively described to the purchaser in writing in terms measurable by scientific physical means and the device demonstrably has those properties.

    Source Urls
    • https://www.medsafe.govt.nz/regulatory/devicesnew/1Definition.asp
    Source Binding

    reviewed

Official Sources
  • Authority

    New Zealand Gazette

    Topic

    Radiocommunications Regulations (Radio Standards) Notice 2025 — SRD AS/NZS 4268 A1 and MICS EN 301 839 A1

    Url

    https://gazette.govt.nz/notice/id/2025-go4751

  • Authority

    Radio Spectrum Management (MBIE)

    Topic

    Supplier Declaration of Conformity required for all A1 radio products

    Url

    https://www.rsm.govt.nz/business-individuals/supplier-compliance/steps/step-4

  • Authority

    New Zealand Legislation

    Topic

    Radiation Safety Act 2016 ss 5, 13, 15 and 17 — source licence, use licence and irradiating apparatus

    Url

    https://www.legislation.govt.nz/act/public/2016/0006/latest/DLM6339547.html

  • Authority

    Medsafe

    Topic

    Other legislation — Electricity Act 1992, Radiocommunications Act 1989, PECPR 1999

    Url

    https://www.medsafe.govt.nz/regulatory/devicesnew/2Legislation.asp

  • Authority

    Medsafe

    Topic

    regulation 62 performance-claim requirements for physical-force devices

    Url

    https://www.medsafe.govt.nz/regulatory/devicesnew/1Definition.asp

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