Skip to main content

Software as a Medical Device (SaMD) and digital health

Current NZ position​

New Zealand does not yet have a dedicated regulatory framework for Software as a Medical Device. The Medicines Act 1981 was enacted decades before modern health software existed. However, Medsafe applies the existing device definition and classification rules to software, referencing IMDRF guidance.

Is your software a medical device?​

Apply the same test as for any other device — is the software intended by its manufacturer to be used for a medical purpose (diagnosis, monitoring, treatment, alleviation of disease, etc.)? The IMDRF definition of SaMD is the reference Medsafe uses:

Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

Examples that are likely medical devices:

  • Diagnostic software that analyses ECG traces to detect arrhythmias
  • AI software that screens mammography images for cancer
  • Apps that analyse patient-reported symptoms to suggest diagnoses
  • Software that monitors chronic conditions and adjusts medication recommendations

Examples that are generally not medical devices:

  • Electronic health record (EHR) systems
  • General administrative software for clinics
  • General wellness and fitness trackers
  • Apps that provide general health information without diagnostic function

Classification of SaMD​

Under Schedule 2, Rule 11 is the primary classification rule for software:

  • Software intended to provide information used for decisions with diagnosis or therapy purposes is at minimum Class IIa
  • Software where failure could result in death or irreversible deterioration of health is Class IIb or III

The IMDRF SaMD Framework (which groups SaMD by state of healthcare situation × significance of information provided) provides a useful cross-check against NZ classification, though Medsafe has not formally adopted the IMDRF tiered framework.

AI and ML-based software​

AI/ML-based software is treated the same as other SaMD for classification purposes under the current framework. The key questions are:

  • What is the intended purpose?
  • What are the consequences if the software fails or provides incorrect output?
  • Is it intended to be used as a standalone diagnostic or therapeutic tool?

Software that uses AI for general-purpose purposes (e.g., scheduling, administrative efficiency) is not a medical device. Software that uses AI to detect disease, guide treatment, or monitor patient health is likely to be.

Medical Products Bill — SaMD provisions​

The upcoming Medical Products Bill will for the first time explicitly regulate SaMD in New Zealand. Cabinet agreed in July 2025 that:

  • The Bill will regulate SaMD (including AI used for a therapeutic purpose)
  • The SaMD definition will be internationally aligned (IMDRF-based)
  • General clinical software and general-use AI will be excluded
  • The Bill will include measures for timely approval of novel and innovative products, including flexible pathways for AI

This will significantly change how software developers must approach the NZ market once the Bill is enacted.

mHealth and wearables​

Mobile health apps and consumer wearables sit on the device/non-device borderline. A fitness tracker that records general activity is not a device. The same hardware running clinical-grade cardiac monitoring software intended for diagnosis may be. Always assess based on the specific intended purpose claimed by the manufacturer.

Borderline software products

Use Medsafe's categorisation service (devices@health.govt.nz) to get an advisory opinion on whether your software is a medical device in New Zealand before investing in WAND notification or technical documentation.