How classification works in NZ
How Medsafe's risk-based classification system works, who is responsible for classifying a device, and how NZ rules align with international frameworks.
The 22 classification rules
A reference guide to the 22 device classification rules in Schedule 2 of the Medicines (Database of Medical Devices) Regulations 2003.
IVD classification
How in vitro diagnostic devices are classified in New Zealand — the four IVD classes, classification rules, and the key difference from non-IVD regulation (IVDs are WAND-exempt).
Special device types
Classification and regulatory treatment of SaMD, combination products, accessories, custom-made devices, reprocessed SUDs, and borderline products in New Zealand.