Medsafe

Name

Medsafe

Legal name

Medsafe (New Zealand Medicines and Medical Devices Safety Authority)

Website

https://medsafe.govt.nz

Company type

Private

Operating status

Operating

Ownership category

akta.pro rank

Headquarters

HQ city

Wellington

HQ country

New Zealand

HQ region

Oceania

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure

Revenue model

1. Regulatory Fees: Medsafe operates as a regulatory authority under the Ministry of Health, funded primarily through government appropriations. The organization charges fees for regulatory evaluation services, including medicine approval processes, manufacturing licenses, and other regulatory submissions as outlined in their Schedule of Fees.
2. Government Funding: Medsafe is a business unit of the Ministry of Health and operates as part of the New Zealand government's health regulatory functions, funded through Crown appropriations.

Pricing tiers

Distribution channels4 records

Marketing channels7 records

Core offering

Medsafe is New Zealand's medicines and medical devices safety authority, operating as a business unit of the Ministry of Health. It evaluates and approves therapeutic products for the New Zealand market, monitors medicine and device safety through proprietary databases (WAND, SMARS, MORD), coordinates product recalls, and publishes regulatory guidance, data sheets, consumer medicine information, and the Prescriber Update newsletter for healthcare professionals, industry sponsors, and consumers.

Product overview

Medsafe is New Zealand's medicines and medical devices regulatory authority, operating as a business unit of the Ministry of Health. The organization offers a portfolio of regulatory databases and information services including the WAND database for medical device notifications, searchable Data Sheets and Consumer Medicine Information databases, the Medsafe Online Recalls Database (MORD), and the Suspected Medicine Adverse Reaction Search (SMARS) database. Additional services include the Prescriber Update newsletter for healthcare professionals, Classification and Label Statements databases, and regulatory guidance services for industry stakeholders including clinical trials oversight, manufacturing compliance, and pharmacy licensing.

Differentiator

Problem solved

Functional benefit

Products and services

• WAND (Web Assisted Notification of Devices)
• Suspected Medicine Adverse Reaction Search (SMARS) Publicly searchable database extracting information from the Centre for Adverse Reactions Monitoring (CARM) covering suspected adverse reactions to medicines used in New Zealand since January 2000.
• Medsafe Online Recalls Database (MORD) Publicly accessible and searchable database providing complete records of all therapeutic product recall actions initiated in New Zealand since 1 July 2012.
• Data Sheets and Consumer Medicine Information (CMI) Search Searchable database of approved medicine data sheets and consumer medicine information published on behalf of pharmaceutical companies for use by healthcare professionals and consumers.
• Classification Database Database containing classification information and scheduling status for medicines regulated in New Zealand.
• Label Statements Database Database of label statement requirements applicable to therapeutic products sold in New Zealand.
• Medicine and Medical Device Regulation Services Statutory regulatory services including medicine evaluation and approval, clinical trial oversight, Good Manufacturing Practice compliance, manufacturing and pharmacy licensing, and policy guidance for pharmaceutical and medical device industries.

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Four partnerships are on record, tiered core, major and minor.

• Centre for Adverse Reactions Monitoring (CARM)coreStrategic or Co-development PartnerCARM, based at the University of Otago, works under contract with the Ministry of Health to collect and monitor adverse reaction reports. Medsafe uses CARM data for the SMARS database and adverse reaction monitoring activities.
• Ministry of HealthcoreOthersMedsafe is a business unit of the Ministry of Health, operating under its governance and funding structure as the statutory authority for medicines and medical devices regulation in New Zealand.
• Therapeutic Goods Administration (TGA) AustraliamajorStrategic or Co-development PartnerMedsafe collaborates with the Australian TGA on the trans-Tasman Early Warning System for medicine and device safety communications, sharing information and coordinating regulatory responses across both jurisdictions.
• The Good Vitamin CominorOthersProduct supplier working with Medsafe during recall coordination. Medsafe is working with the supplier for recall of Kids Good Multi gummies batches.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Health Canada — Health Products and Food Branch: Canadian federal authority regulating medicines and medical devices. Functionally analogous to Medsafe with similar scope over therapeutic product approval, monitoring, and recalls.
• National Medical Products Administration (NMPA): China's national regulator for medicines and medical devices. Comparable statutory mandate across therapeutic product approval, post-market monitoring, and recall coordination.
• Medicines and Healthcare products Regulatory Agency (MHRA): United Kingdom's national regulator for medicines, medical devices, and blood components. Comparable in scope, statutory authority, and post-market surveillance functions to Medsafe.
• Swissmedic: Swiss national medicines and medical devices authority. Comparable in mandate, scope, and operation as a standalone national regulatory agency with similar small-jurisdiction profile.
• Therapeutic Goods Administration (TGA): Australia's national medicines and medical devices regulator. Closest functional peer to Medsafe given the existing trans-Tasman partnership and similar statutory mandate over therapeutic goods.
• Pharmaceuticals and Medical Devices Agency (PMDA): Japan's national regulator for pharmaceuticals and medical devices. Equivalent scope to Medsafe with parallel functions across approval, safety surveillance, and recalls.
• Health Sciences Authority (HSA): Singapore's regulator for health products including medicines and medical devices. Comparable small-market national regulator with similar regulatory and pharmacovigilance responsibilities.
• ANVISA: Brazilian Health Regulatory Agency overseeing medicines, medical devices, and health products. Equivalent national regulator with parallel approval, pharmacovigilance, and recall functions.

Broad incumbents

• European Medicines Agency (EMA): EU-wide regulator for human and veterinary medicines. Operates a supranational version of Medsafe's medicines mandate; not a direct country-level peer but the dominant benchmark for small national regulators.
• U.S. Food and Drug Administration (FDA): The largest national medicines and medical devices regulator globally. Overlaps with Medsafe in medicines and device approval, post-market surveillance, and recall authority but at vastly greater scale and scope.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights5 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Medsafe