Medicines Act Compliance

Labelling, IFU & Advertising Compliance (New Zealand)

The Marketed Product Must Remain Consistent With Its Intended Purpose and Evidence. Labelling and Instructions for Use should accurately communicate the device identity, intended purpose, safe use, warnings and manufacturer/sponsor information required for the New Zealand market. Advertising should not make misleading or unsupported therapeutic claims.

Review Your New Zealand Labelling

When This Support Is Needed

Preparing product labels, packaging artwork, and Instructions for Use (IFU) for New Zealand market launch

Verifying that commercial brochures, websites, and marketing materials comply with Medsafe advertising rules

Adding New Zealand Sponsor legal contact details to primary/secondary packaging or user manuals

Updating storage temperature, sterility, or clinical indication statements on packaging

What We Challenge Before Submission

Are the legal manufacturer and New Zealand Sponsor clearly identified on packaging or documentation?

Do promotional marketing claims in brochures strictly reflect the clinical evidence in the technical file?

Does marketing material avoid prohibited therapeutic claims under Section 58 of the Medicines Act?

Are all model numbers, catalogue codes, and batch/lot symbols aligned with the WAND database record?

Are temperature, humidity, sterility, and expiration symbols completely aligned with stability validation reports?

Our Labeling & Advertising Review Scope

Product label and Instructions for Use (IFU) regulatory compliance review against NZ Regulations

Legal manufacturer and New Zealand Sponsor identification on packaging and user documentation

Intended clinical purpose and therapeutic claims alignment with technical evidence

Warnings, precautions, contraindications, and residual risk statement harmonization

Standardized symbol verification (ISO 15223-1) and storage/sterility condition labeling

Sterile, measuring, and implantable device specific labeling information review

Electronic Instructions for Use (e-IFU) eligibility assessment and compliance

IVD-specific labeling, specimen handling, and diagnostic performance claims review

Advertising, brochure, and commercial marketing claim review under the Medicines Act 1981

Regulatory impact assessment for post-approval packaging revisions and artwork updates

Consistency Standard:

We compare the marketed claims against the technical evidence, risk controls and WAND/sponsor information. A commercial label change can become a regulatory issue if it alters intended purpose, device description, safety information or the basis on which the sponsor classified and supplied the device.

Harmonize Packaging Artwork and Promotional Claims for New Zealand

Our labeling consultants audit artwork for Medsafe compliance, verify sponsor details, and review marketing claims.

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