Regulatory Strategy & Product Classification (New Zealand)

Classification Drives the New Zealand Sponsor and WAND Strategy. New Zealand uses a GHTF-based medical-device classification framework with Class I, Class I sterile/measuring, Class IIa, Class IIb, Class III and AIMD categories. Classification is determined using the rules in Schedule 2 and must be assigned by the New Zealand Sponsor when notifying a device to WAND.

Define Your New Zealand Regulatory Pathway

When This Support Is Needed

Introducing a new medical device, IVD, SaMD, or accessory into the New Zealand market

Determining the applicable risk class under Schedule 2 of the Medicines (Database of Medical Devices) Regulations 2003

Selecting the correct GMDN code and collective term for WAND database notification

Evaluating whether a device qualifies for statutory WAND exemption (e.g. In Vitro Diagnostics)

An engineering modification or clinical claim expansion may alter the established risk class

What We Challenge Before Submission

Does the product qualify as a medical device under Section 3A of the Medicines Act 1981?

Will a clinical marketing claim shift the device into a higher risk class under Schedule 2?

Does the GMDN code accurately reflect the intended medical purpose and technology?

Are all system accessories and consumables correctly grouped or classified separately?

Can the New Zealand Sponsor defend the declared classification if Medsafe initiates a safety audit?

Our Classification & Strategy Scope

Product qualification and regulatory-status assessment under the Medicines Act 1981

Intended clinical purpose, indications, claims, and target user-population review

Schedule 2 risk-class determination (Class I, Class I sterile/measuring, Class IIa, Class IIb, Class III, AIMD)

Accessory, procedure pack, and medical device system classification considerations

Software as a Medical Device (SaMD) and digital health regulatory status assessment

GMDN code selection, preferred term verification, and descriptor mapping

Assessment of mandatory WAND notification vs statutory exemption

Cross-market equivalence review (comparing EU MDR, Australian TGA, and US FDA classifications with NZ rules)

Comprehensive regulatory roadmap from sponsor appointment through post-market compliance

Classification Strategy Standard:

We do not simply map a foreign-market class into New Zealand. We apply the New Zealand rules and then trace that classification into the WAND data set, grouping strategy, sponsor declaration, technical-evidence expectations and post-market controls that follow.

Classify Your Medical Device Under New Zealand Schedule 2 Rules

Our New Zealand regulatory strategists evaluate intended purpose, determine risk classes, and assign optimal GMDN codes.

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