Quality System Overview

Medsafe · Medicines Act 1981 · GHTF SG3 · Sponsor obligations

Key Difference: No Mandatory ISO 13485

Unlike the EU, Australia, UK, Canada, and most major markets, New Zealand does not require ISO 13485 certification as a condition of WAND notification or market supply. There is no mandated conformity assessment procedure and no requirement to present a certificate from an accredited certification body.

Instead, New Zealand uses a post-market accountability model: the Sponsor declares the device is safe and suitable for supply, and must be able to substantiate that claim if Medsafe asks.

NZ-Unique

This is one of the most significant differences between New Zealand and comparable markets. Manufacturers accustomed to submitting ISO 13485 certificates as part of pre-market applications should note that NZ does not require this upfront — but that does not mean quality documentation is optional.

What Medsafe Expects

Although ISO 13485 is not mandated, Medsafe expects that the manufacturer of any device supplied in New Zealand maintains a quality management system appropriate to the device's risk. Specifically, Medsafe can request documentation at any time demonstrating that:

Element	What Is Expected
Design controls	Design and development records showing the device was developed systematically
Risk management	Risk management activities aligned with ISO 14971
Production controls	Manufacturing controls ensuring consistent device quality
Testing and verification	Pre-market testing records supporting safety and performance claims
Post-market feedback	System for collecting and acting on adverse event and complaint data

For devices already cleared by a recognised overseas regulator (EU, TGA, FDA, Health Canada), the conformity assessment documentation from that process serves as sufficient evidence of the manufacturer's quality system. See Conformity Evidence.

Sponsor Quality Obligations

The New Zealand Sponsor carries legal responsibility for every device they supply. Quality obligations specific to the Sponsor role include:

Distribution Records

Sponsors must maintain distribution records sufficient to enable a complete and rapid recall. Records should capture:

• Device identity (model, lot/batch number)
• Customer details (name, address, contact)
• Quantity and date supplied

There is no prescribed format but records must be retrievable quickly. See Recalls and FSCAs.

Complaint Handling

Sponsors must have a process for:

1. Receiving complaints from customers, healthcare providers, and patients
2. Evaluating whether the complaint constitutes a reportable adverse event
3. Reporting to Medsafe within required timeframes
4. Documenting the outcome and any corrective action taken

See Adverse Event Reporting.

Adverse Event Response

When a Sponsor receives adverse event information from the manufacturer or market, they must assess it against Medsafe's reporting thresholds and submit reports where required. The Sponsor is the regulatory interface — Medsafe holds the Sponsor accountable, not the overseas manufacturer directly.

Recall Readiness

Sponsors must be prepared to execute a recall or FSCA at short notice, including:

• Ability to identify and contact all customers who received affected stock
• Capability to issue a Field Safety Notice in the required format
• Coordination with Medsafe throughout the recall process

Good Distribution Practice (GDP)

Importers and distributors must maintain Good Distribution Practice for all devices handled:

Requirement	Detail
Storage conditions	Devices stored per manufacturer's specifications (temperature, humidity, light)
Stock segregation	Approved, quarantined, returned, and rejected stock must be kept separate
FIFO rotation	First-in first-out stock management to prevent expiry
Transport controls	Devices transported under conditions that maintain product integrity
Traceability	Batch/lot numbers recorded at each distribution step

Medsafe can inspect distributor premises as part of market surveillance activities. Inadequate storage conditions or missing distribution records are common enforcement triggers.

ISO 13485 — Strongly Recommended Despite No Mandate

Even though ISO 13485 is not required, Medsafe's own guidance documents reference GHTF SG3 (the precursor to ISO 13485) as the standard for medical device quality systems. Practical reasons to maintain ISO 13485 certification include:

• Multi-market efficiency: Most major markets (EU, TGA, FDA, Health Canada, Japan, Korea) require or reference ISO 13485. Holding certification simplifies documentation across all markets.
• Medsafe documentation requests: ISO 13485 certification is the easiest way to satisfy Medsafe if they request evidence of manufacturing quality controls.
• Medical Products Bill: The upcoming Bill is expected to introduce formal QMS requirements. Being ISO 13485 certified now prepares manufacturers for this change.
• Credibility with healthcare providers: Hospitals and procurement bodies often request ISO 13485 certificates even where not legally required.

Medical Products Bill — Expected QMS Changes

The Medical Products Bill (expected to replace the Medicines Act 1981) is anticipated to introduce:

• Formal conformity assessment requirements, likely including QMS certification for higher-risk device classes
• Mandatory ISO 13485 (or equivalent) for Class II–IV devices
• Alignment with international frameworks, removing NZ's current divergence from global QMS expectations

Until the Bill is enacted, the current model — no mandated certification, but full accountability on the Sponsor — remains in force. See Medical Products Bill for current status and timeline.

Practical Checklist for Sponsors

Before supplying a device in New Zealand, confirm:

• Manufacturer holds evidence of quality management system (ISO 13485 certificate or equivalent documentation package)
• Technical documentation exists and can be provided to Medsafe within the timeframe specified in any information request
• Distribution record system is in place
• Complaint handling process is operational
• Adverse event reporting thresholds are understood and a reporting process is set up
• Storage and handling conditions meet manufacturer specifications
• Recall readiness plan exists