Launching a health product can be exciting - but it can also feel like you’ve stepped into a whole new world of rules, approvals, advertising limits and product safety obligations.
If you’re selling (or planning to sell) a “therapeutic good” in New Zealand - whether that’s a supplement, a skincare product with bold claims, a medical device, or a medicinal cannabis product - you’ll want to get your legal foundations right from day one. It’s one of those areas where a small compliance mistake can cause big delays (or big headaches) later.
This guide is updated to reflect current regulatory expectations and the practical compliance focus we’re seeing right now. We’ll break down how Medsafe fits into the picture, how to classify your product, what approvals and notifications you might need, and how to avoid common pitfalls when marketing and selling in NZ.
Important note: this is general information only. Therapeutic goods regulation is very fact-specific - what you need to do depends on exactly what your product is, what it contains, and the claims you make. If you’re unsure, it’s worth getting tailored advice before you invest heavily in packaging, stock, influencer campaigns or ecommerce.
What Does Medsafe Do (And When Do You Deal With Them)?
Medsafe is the New Zealand Medicines and Medical Devices Safety Authority. In plain terms, Medsafe is one of the key regulators that helps ensure medicines and medical devices supplied in New Zealand are safe, effective (where applicable), and appropriately controlled.
You’ll usually deal with Medsafe when:
- your product is (or might be) a medicine under NZ law;
- your product is a medical device (including many software-based health tools);
- you’re importing, manufacturing, distributing, wholesaling or exporting regulated therapeutic products;
- you’re making therapeutic claims that can push a “wellness” product into regulated territory; or
- you’re entering a tightly controlled area like medicinal cannabis (for that, a Medicinal Cannabis Business should treat regulatory compliance as a core part of the business model, not an afterthought).
One of the trickiest parts is that the same “type” of product (say, a topical cream) can be regulated in completely different ways depending on:
- the ingredients (active vs cosmetic ingredients);
- the intended purpose (treat vs soothe vs moisturise); and
- the claims you make on packaging, your website, social media, or through affiliates.
So, before you order 10,000 units of packaging (or spend money on ads), it’s worth doing a classification check and mapping your compliance steps.
Is Your Product A Medicine, Medical Device, Cosmetic, Or Supplement?
A lot of compliance issues start with a simple problem: the founder thinks they’re selling a “wellness product”, but the law treats it as a medicine (or a medical device). Getting the classification right is step one because it affects approvals, manufacturing standards, import requirements, and what you can say in your marketing.
Medicines (Including “Natural” Or Herbal Products)
In New Zealand, products can be considered “medicines” even if they’re marketed as natural, herbal, traditional or alternative. If you’re making claims that your product can treat, prevent, or diagnose a condition, you may be in medicine territory.
Common examples that can trigger medicine regulation include products claiming to:
- treat anxiety, insomnia, ADHD, depression, eczema, acne, or chronic pain;
- lower blood pressure or cholesterol;
- support “immune defence” in a way that implies prevention of illness;
- detox the liver or “repair” organs;
- balance hormones in a therapeutic way.
Even if you don’t use these exact words, images, testimonials, before/after photos, and influencer captions can create the overall impression of a therapeutic claim.
Medical devices cover a wide range - from bandages and thermometers through to diagnostic tools and certain health-related software.
In many cases, the “device” isn’t regulated because of what it is physically, but because of what it’s intended to do. For example, software that:
- diagnoses a condition;
- predicts medical outcomes;
- monitors a patient for clinical management; or
- supports treatment decisions,
may be regulated differently to a general wellness tracker.
Dietary Supplements And Foods With Health Claims
Some products sit in a space that feels like medicine, but isn’t necessarily regulated as one. Supplements and certain food products can still have strict rules around composition, safety, labelling and health claims.
This is where founders often get caught out: even if you’re not regulated as a “medicine”, you’re still exposed to consumer law, product safety expectations, and advertising standards (more on that below).
Cosmetics And Skincare
Skincare brands often assume they’re “just cosmetics” - but therapeutic claims can change that fast. “Helps reduce the appearance of redness” might be cosmetic; “treats rosacea” is more likely to be treated as therapeutic.
If you’re blending cosmetic positioning with medical-style results, it’s worth getting advice before you commit to claims, packaging and influencer scripts.
What Regulatory Steps Do You Need Before You Sell In NZ?
There isn’t one single “Medsafe licence” that covers everything. Your steps depend on your product category, supply chain, and business model (NZ-made vs imported, direct-to-consumer vs wholesale, online vs clinic, etc.).
That said, most therapeutic goods businesses should work through the following checklist.
1. Confirm Your Product Classification Early
Before you build your brand around a promise (“clinically proven to fix X”), lock in the classification and compliance pathway. This step affects:
- whether product approval/consent is required;
- whether you need to meet specific manufacturing standards;
- whether you can legally make certain claims; and
- what documentation you’ll need if you’re audited or challenged.
It’s also crucial if you plan to sell in multiple countries - what’s a “cosmetic” in one market may be a regulated therapeutic product in another.
2. Map Your Supply Chain (Importing, Manufacturing, Storage, Distribution)
Your obligations can change based on what you actually do in the supply chain. For example:
- If you import finished products, you’ll need to ensure the overseas manufacturer meets standards and your importation and labelling are compliant.
- If you manufacture or package locally, you may need stronger quality systems and documentation.
- If you store products (especially temperature-sensitive goods), you’ll want procedures around storage and handling.
Many businesses underestimate how important traceability is. If something goes wrong (contamination, mislabelling, adverse reaction), you’ll want to be able to identify batches, suppliers, and customers quickly.
3. Get Your Labelling And Packaging Right
Labelling is not just a branding exercise - it’s part of compliance. Packaging can be non-compliant because it’s missing required information, includes misleading claims, or implies therapeutic use beyond what’s permitted.
A practical way to reduce risk is to treat your packaging as a legal document that needs review (before printing). If you’re building a consumer product brand, a Labelling And Packaging Requirements checklist is a good starting point for identifying common issues to watch for.
4. Understand Your Product Safety And Liability Exposure
Even with strong compliance, things can go wrong - a supplier changes an ingredient, a customer has an allergic reaction, a batch is contaminated, or a product doesn’t perform as advertised.
From a legal perspective, you should think about:
- product liability risk (including defects, injuries, or misleading marketing);
- recall readiness (can you contact customers and remove stock quickly?);
- documentation (testing, certificates of analysis, ingredient traceability); and
- insurance (product liability cover is often essential, especially if you’re scaling).
In New Zealand, consumer and safety issues can create serious financial and reputational damage, even if you didn’t “intend” to mislead. If you want a deeper sense of the risk landscape, Product Liability In NZ is a helpful concept to understand early.
Some categories (like medicinal cannabis) involve additional licensing, prescribing pathways, distribution constraints, and advertising limitations. You’ll want a compliance plan that covers:
- who you can sell to (patients, pharmacies, clinics, wholesalers);
- how products are supplied and prescribed;
- what claims you can and can’t make; and
- how you will store, distribute, and manage records.
This is one of those areas where it’s smart to get advice early - changing direction later can be expensive.
What Are The Rules For Advertising Therapeutic Goods In NZ?
Marketing is where a lot of businesses accidentally create compliance risk. The more effective your marketing is, the more important it becomes that your claims are accurate, substantiated, and allowed for your product category.
Be Careful With Therapeutic Claims
If you advertise that your product can treat or prevent a condition, you may trigger medicine/device regulation - even if you didn’t intend to. This includes:
- website copy and product pages;
- social media posts, reels and captions;
- paid ads and advertorials;
- influencer scripts and affiliate content;
- testimonials and reviews you repost; and
- before/after images.
In addition, regardless of whether Medsafe is involved, you generally must comply with the Fair Trading Act 1986, which prohibits misleading and deceptive conduct and false or unsubstantiated representations. That means you should be able to back up claims like “clinically proven”, “works in 7 days”, or “guaranteed results” with real evidence.
Online Sales And “Digital Pharmacy” Style Models
If you’re selling therapeutic goods online, you’ll also want to think about:
- how you describe your products (and whether that description changes their classification);
- whether you’re offering information that looks like diagnosis or prescribing;
- how you handle age restrictions or controlled products; and
- what customer support you provide (and what you should avoid saying).
Some business models blur the line between ecommerce and healthcare delivery, so it’s worth checking the legal boundaries early. If your offering starts to look like an online pharmacy model, the question of Online Pharmacies and what’s permitted becomes very relevant.
Email, SMS And Direct Marketing Rules
If you’re building a customer list (especially for repeat purchase products like supplements), don’t forget the marketing compliance side. You’ll want customer consent processes and unsubscribe functionality in place.
This is particularly important if you’re running automated flows (welcome series, abandoned cart, subscription reminders) because the volume can scale quickly. Getting your Email Marketing Laws settings right from the start can save you a lot of risk later.
Therapeutic goods businesses often collect more sensitive data than a normal retail store - for example:
- customer health concerns (even if it’s just “I bought this for my eczema”);
- quiz results (“find the right supplement for you”);
- subscription preferences tied to health outcomes; or
- consultation notes if you offer practitioner support.
In NZ, privacy compliance is governed by the Privacy Act 2020. If you collect personal information online (especially anything health-related), you should usually have a clear Privacy Policy and make sure your data handling practices match what you tell customers.
Even if you’re not running a clinic, trust is everything in health products - privacy is part of that trust.
How Do You Protect Your Therapeutic Goods Business With The Right Legal Documents?
Regulatory compliance is only one part of running a therapeutic goods business. You also need solid contracts and legal documents so the business is protected as you grow - especially because you’ll often deal with manufacturers, formulators, distributors, marketers, affiliates, clinics, and logistics providers.
Here are some of the key documents and legal areas to think about.
Supplier And Manufacturing Agreements
If you’re using a contract manufacturer (in NZ or overseas), don’t rely on a short quote and a couple of emails. You’ll want a written agreement that covers things like:
- product specifications (including permitted ingredient substitutions);
- quality control, testing, and batch documentation;
- who is responsible for label compliance and approvals;
- intellectual property (who owns the formula, packaging artwork, brand assets);
- warranties and indemnities if the product is defective; and
- what happens if you need a recall.
Ecommerce Terms, Refunds And Consumer Guarantees
Most therapeutic goods are sold to consumers, which means you need to get your customer-facing terms right. In New Zealand, the Consumer Guarantees Act 1993 and Fair Trading Act 1986 commonly apply.
This affects:
- how you describe products and results;
- your returns and refunds process (including what you can and can’t exclude);
- subscription terms and cancellation rights; and
- any “money back guarantee” claims.
If you sell through your own site, marketplaces, or stockists, it’s worth aligning your customer terms with your real operational process so you can deliver on what you promise.
Distribution And Stockist Agreements
If you’re scaling into pharmacies, health stores, clinics, or distributors, you’ll want agreements that clearly set out:
- territory (if any) and resale channels;
- minimum advertised pricing (handled carefully to avoid competition issues);
- marketing obligations and brand guidelines;
- who handles complaints and adverse event reports; and
- recall cooperation and notification requirements.
If you run an online store, you’ll often need a set of website and ecommerce documents that match what you actually do, including:
- terms and conditions of sale (especially for subscriptions);
- shipping and returns policies; and
- privacy disclosures for analytics, ad pixels, and customer profiling.
These are also part of brand trust - clear terms can reduce disputes and chargebacks.
Cross-Border Selling (Especially Australia)
Many NZ wellness and therapeutic brands expand into Australia early. If that’s your plan, you’ll want to check whether your product is regulated as a therapeutic good there and whether you need to comply with additional requirements.
For example, some products that are lightly regulated in NZ may be more strictly regulated across the Tasman. A Therapeutic Goods Administration Guide can be a useful reference point when you’re mapping out an Australia expansion strategy.
The key is to design your product claims, labels, and evidence pack with cross-border growth in mind - changing labels after you’ve built brand recognition is painful (and expensive).
Key Takeaways
- Medsafe regulation depends heavily on product classification, which can change based on ingredients, intended use, and the claims you make in marketing.
- If your product is (or looks like) a medicine or medical device, you may need to meet specific regulatory requirements before you sell in New Zealand.
- Even if your product isn’t regulated as a medicine, you still need to comply with key laws like the Fair Trading Act 1986 and Consumer Guarantees Act 1993, especially around advertising and refunds.
- Advertising is a common risk area - therapeutic claims can trigger regulation, and unsubstantiated performance claims can breach consumer law.
- If you collect health-related or sensitive customer data (even through quizzes or support emails), you should treat privacy compliance under the Privacy Act 2020 as a core part of your business foundations.
- Strong contracts with manufacturers, suppliers, stockists and marketers help manage quality control, liability and recall risk - templates usually won’t cover the realities of therapeutic goods properly.
- If you’re unsure about your product classification or what you can legally say in marketing, getting tailored advice early can save you time and costly rework later.
If you’d like help getting your therapeutic goods business legally set up - including reviewing your product claims, drafting or negotiating supply and distribution contracts, or putting the right website terms and privacy documents in place - you can reach us at 0800 002 184 or team@sprintlaw.co.nz for a free, no-obligations chat.
