Change, Notification & Lifecycle Support (New Zealand)

Changes Can Affect WAND Data, Classification and the Sponsor Declaration. Device, manufacturer, sponsor, intended-purpose and product-information changes should be assessed before implementation because they may affect the New Zealand classification, WAND record, technical evidence, labelling or post-market controls.

Assess a New Zealand Device Change

When This Support Is Needed

Design, raw material, or engineering specification changes planned for a device notified in WAND

Manufacturing site transfer, contract sterilizer change, or critical component supplier change

Releasing a software version update, algorithmic revision, or cybersecurity patch

Updating product labeling, packaging artwork, or expanding clinical intended use claims

A change in New Zealand Sponsor, importer corporate details, or local distributor arrangements

What We Challenge Before Submission

Does the planned engineering change alter the established Schedule 2 risk classification or intended purpose?

Does the change require an update to existing WAND records within statutory regulatory timeframes?

Do existing pre-clinical bench, biocompatibility, and sterilization test reports still represent the modified device?

Are changes to legal manufacturer corporate data or site addresses reflected across all technical records?

Is notified WAND information corrected promptly when it becomes inaccurate, in line with sponsor obligations?

Our Lifecycle Change Management Scope

Regulatory change impact assessment against New Zealand legal requirements and Medsafe guidance

Change categorization and determination of WAND notification amendment vs new notification

Technical file update strategy and verification/validation evidence gap closure

Risk management file review and ISO 14971 benefit-risk re-evaluation

Clinical evaluation and IVD performance evidence impact assessment

Manufacturing site, sterilizer, and ISO 13485 QMS certificate change management

Label and IFU revision review and harmonization with technical evidence

GMDN code / device-description change assessment and WAND record correction

Sponsor and importer change management in the Medsafe database

Post-market regulatory record maintenance and lifecycle governance

Lifecycle Assessment Rule:

We determine whether the change requires technical-evidence updates, a new or amended WAND notification, correction of sponsor/manufacturer data, revised labelling, additional validation or another lifecycle action. WAND information that becomes inaccurate should be corrected promptly in accordance with sponsor obligations.

Manage WAND Database Variations and Lifecycle Compliance

Our regulatory strategists assess change impact, submit WAND database updates, and maintain sponsor compliance.

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