New Zealand Product Registration & Certification
Important Notes
- Medsafe Regulation & WAND Database: All medicines, medical devices (including IVDs), and related products are regulated by Medsafe. Approved devices are listed in the Web Assisted Notification of Devices (WAND) database.
- Risk-Based Classification & Pathway: Medical devices follow GHTF/IMDRF risk classification rules (Class I-IV), determining the conformity assessment procedure (self-declaration, audit assessment, or Medsafe conformity assessment).
- Sponsor (Authorized Representative) Requirement: Foreign manufacturers must appoint a "Sponsor" located in New Zealand or Australia as the regulatory contact with Medsafe and assume product responsibility.
- Labeling & Instructions Requirements: All information must be in English. Labels must comply with the Medicines and Medical Devices Labeling Guide, including sponsor details, NZ Unique Device Identifier (if applicable), and key safety information.
- Joint Scheme with Australia (TTMA): Under the Trans-Tasman Mutual Recognition Agreement, some devices complying with Australian TGA requirements can access the NZ market via a streamlined process, and vice versa.
- Pharmac Funding Approval (Medicines): For government subsidy, medicines must apply separately to the Pharmaceutical Management Agency (Pharmac) for funding, which conducts cost-effectiveness assessments独立 of Medsafe's safety/efficacy approval.
New Zealand Specific Requirements
- Small but Sophisticated High-Standard Market: The market is limited in size but maintains high regulatory standards aligned with major international markets (especially Australia and the EU), with stringent and transparent processes.
- Pharmac-Driven "Value-Based Procurement" Model: As the single payer, Pharmac wields significant negotiating power. Its cost-effectiveness-based procurement decisions profoundly influence medicine market access and pricing, though negotiations can be lengthy.
- Close Synergy with the Australian Market: Through agreements like TTMA, NZ and Australia have deep regulatory alignment for devices, making Australian approval the most efficient route to NZ, though medicine approval and funding are独立.
- Openness to Digital Health & Telehealth: The government actively supports digital health solutions and telehealth services, with relatively clear and favorable regulatory pathways for related products.
- Pragmatic & Lifecycle-Oriented Regulation: Medsafe emphasizes lifecycle risk management and post-market surveillance, responding promptly to safety signals.
Medical Devices Registration
Regulatory Requirements
- WAND Database Listing (Web Assisted Notification of Devices)
- Classification Management by Risk Level (Class I, IIa, IIb, III)
- Declaration of Conformity
- Quality Management System Certificate (ISO 13485)
- English Labeling and Instructions for Use
- Technical Documentation File
- Clinical Evaluation Report (if applicable)
- New Zealand Authorized Representative Agreement
- Post-Market Surveillance Plan
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Conformity Assessment Completion
- New Zealand Representative Appointment
- WAND Database Listing
- Market Access Completion
Registration Timeline
4-12 months
Official Fees
NZD 1,500 - 25,000
Service Fees
$10,000 - $30,000
Regulatory System Overview
Medsafe
New Zealand Medicines and Medical Devices Safety Authority
Responsible for medical device regulation, WAND database management, market surveillance, and adverse event monitoring. Operates as the primary medical device regulatory authority under the New Zealand Ministry of Health.
MPI
Ministry for Primary Industries New Zealand
Responsible for food and dietary supplement safety regulation, standards development, and compliance supervision. Ensures food safety and labeling compliance.
EPA
Environmental Protection Authority New Zealand
Responsible for chemicals management, including assessment, approval and regulation of hazardous substances and new chemical ingredients used in cosmetics
Medical Devices Registration Process
Product Classification Determination
Determine product risk classification according to New Zealand medical device regulations (Class I, IIa, IIb, III)
Technical Documentation Preparation
Prepare complete technical documentation including declaration of conformity, clinical evaluation, risk management files
New Zealand Authorized Representative
Appoint authorized representative in New Zealand responsible for WAND database registration and regulatory affairs
WAND Database Listing
Complete medical device listing through Web Assisted Notification of Devices system
Declaration of Conformity
Manufacturer signs declaration of conformity confirming product compliance with New Zealand regulations
Cosmetics Registration
Regulatory Requirements
- Product Safety Assessment Report
- Ingredient Compliance Confirmation
- English Product Labeling
- Good Manufacturing Practice Certification
- Product Information File
- Ingredient Safety Data
- Stability Study Data
- New Zealand Responsible Party Appointment
Main Process
- Ingredient Compliance Assessment
- Safety Assessment Completion
- Responsible Party Appointment
- Labeling Review Preparation
- Product Information File Establishment
Registration Timeline
3-6 months
Official Fees
NZD 800 - 5,000
Service Fees
$5,000 - $15,000
Regulatory System Overview
Medsafe
New Zealand Medicines and Medical Devices Safety Authority
Responsible for medical device regulation, WAND database management, market surveillance, and adverse event monitoring. Operates as the primary medical device regulatory authority under the New Zealand Ministry of Health.
MPI
Ministry for Primary Industries New Zealand
Responsible for food and dietary supplement safety regulation, standards development, and compliance supervision. Ensures food safety and labeling compliance.
EPA
Environmental Protection Authority New Zealand
Responsible for chemicals management, including assessment, approval and regulation of hazardous substances and new chemical ingredients used in cosmetics
Cosmetics Registration Process
Ingredient Compliance Assessment
Verify all ingredients comply with New Zealand cosmetic regulations
Safety Assessment Report
Prepare product safety assessment report signed by qualified assessor
New Zealand Responsible Party
Appoint responsible party in New Zealand for product compliance and market surveillance
Labeling Compliance Review
Ensure labeling complies with New Zealand cosmetic labeling regulations
Product Information File
Establish complete product information file including all technical data
Dietary Supplements Registration
Regulatory Requirements
- Dietary Supplement Compliance Statement
- Ingredient Safety and Quality Proof
- English Product Labeling
- Good Manufacturing Practice Certification
- Ingredients and Claims Compliance
- Nutritional Composition Analysis
- Heavy Metals and Contaminants Testing
- Microbiological Test Reports
Main Process
- Ingredient Compliance Assessment
- Technical Documentation Preparation
- Labeling Review Preparation
- Compliance Statement Signing
- Market Access Completion
Registration Timeline
3-7 months
Official Fees
NZD 500 - 3,000
Service Fees
$6,000 - $16,000
Regulatory System Overview
Medsafe
New Zealand Medicines and Medical Devices Safety Authority
Responsible for medical device regulation, WAND database management, market surveillance, and adverse event monitoring. Operates as the primary medical device regulatory authority under the New Zealand Ministry of Health.
MPI
Ministry for Primary Industries New Zealand
Responsible for food and dietary supplement safety regulation, standards development, and compliance supervision. Ensures food safety and labeling compliance.
EPA
Environmental Protection Authority New Zealand
Responsible for chemicals management, including assessment, approval and regulation of hazardous substances and new chemical ingredients used in cosmetics
Dietary Supplements Registration Process
Ingredient Compliance Assessment
Verify all ingredients comply with New Zealand dietary supplement permitted lists
Nutrition Claims Review
Review all nutrition and health claims for New Zealand regulation compliance
Labeling Compliance Review
Ensure labeling fully complies with New Zealand food labeling regulations
Technical Documentation Preparation
Prepare complete technical documentation including ingredient analysis, safety evidence
Compliance Statement
Manufacturer signs compliance statement confirming product meets New Zealand food standards