Medical Device Copywriter in Australia

Amisha Sharma is a medical device copywriter in Australia and an ISB alumna at Commas & Chaos. She writes product and website copy to the intended purpose in your ARTG entry and to the Therapeutic Goods Advertising Code 2021. The largest penalty ever handed down under the Therapeutic Goods Act, $22 million, came from a gap between an ARTG entry and what a company actually did, with no patient harmed. Every page she writes is checked 226 ways before it ships.

01

01The difference

Same device. Two ways to write it.

✗ What most device companies write

"Clinically proven to treat chronic pain and prevent long-term joint damage. The best monitoring device on the market."

Two failures. Treat and prevent are claims that have to sit inside the intended purpose in the ARTG entry, and a reference to a serious condition is a restricted representation that needs TGA permission. Best on the market is a superiority claim that has to be substantiated.

vs

✓ What I write

"A monitoring device for continuous measurement in the settings listed in its ARTG entry. What it measures, how it is used, what the data shows, and who it is intended for."

It reads as more capable, not less. Specifics about performance, workflow and evidence beat adjectives with every buyer who has ever run a procurement process.

Compliant copy has a reputation for being boring. That is a writing problem, not a compliance one. I fix the writing.

Start a conversation →

The $22 million gap

Your ARTG entry is the script. Marketing keeps writing a better one.

On 19 September 2024 the Federal Court ordered Medtronic Australasia to pay $22 million, plus $1 million toward the TGA's legal costs, over 16,267 units supplied to 109 hospitals in a way the ARTG entry did not permit. There were no reports of injury or harm. The whole case sat in the gap between the entry and what the business actually did. Your copy lives in that same gap. Check your site in 60 seconds, whether it is live or still being written.

Six quick questions. Your results, straight away.

02

02What I write

Your whole device site, start to finish.

I'm a medical device copywriter. Your website is the core, and it's where most device companies start. Need Google Ads, social, or SEO articles too? I write those as well.

The website · the core

⌂

Homepage

The page that decides if they stay or bounce.

✎

Service pages

Each product, written inside its intended purpose.

✿

About

Your company, your evidence, your quality story.

?

FAQ & trust pages

The questions people are too shy to ask.

✱

Landing pages

For a campaign or a single service.

Beyond the website · if you want it

◎

Google Ads copy

Campaigns that clear the Code before they clear procurement.

♥

Social media copy

Captions that survive Meta review and the rules.

↗

SEO articles

The questions buyers and clinicians search before a demo.

▤

Content strategy

What to publish, where, and in what order.

One writer for all of it. Quoted flat, upfront.

03

03Why device companies hire me

Four jobs. One writer.

0

delivered pages flagged by a regulator

Written to the intended purpose, not around it.

It is an offence to advertise a medical device that is not in the ARTG, and prohibited to promote a device for a purpose outside its entry. That entry is the boundary of what your copy may claim. I read the entry first and write to it, so regulatory sign-off stops being the stage where marketing goes to die. No delivered work of mine has been flagged by a regulator to date.

↗

Built to get found, not buried.

I structure your pages so Google and AI search can understand them. That gives you a real shot at showing up when someone searches for a device like yours, by name or by category.

✎

Premium, so procurement takes you seriously.

Copy that reads like a company with a quality system behind it. Clinicians and procurement teams can tell the difference in a paragraph, and it changes how your price is received.

My eyes on every word. Every time.

You are never a ticket number in an agency queue. Your pages are never handed to a junior or a content mill. You brief me, I write, and the person answering your email is the person who wrote your homepage. That is why the quality holds, from page one to page fifty.

the whole point

Every sponsor lodges the same entry.
Your words are what's yours.

and the right words survive sign-off

04

04How it works

Three steps, and you never write a word.

01

Send a brief

Tell me about your product and what you need written. Five minutes.

02

We talk

A 30-minute call, then one flat fee. No hourly billing, no lock-in.

03

I write

Every page written, checked, and handed over ready to publish. Two rounds of edits.

05Who writes your copy

Amisha Sharma.

I'm Amisha Sharma, a compliance-first copywriter for regulated Australian brands, medical devices included. I am an ISB alumna, agency trained on Australian accounts. No delivered work of mine has been flagged by a regulator to date. My job is copy that passes regulatory review, ranks on Google, gets quoted by AI, and still sounds like a human wrote it. Every page runs through my 226-point GhostRank audit before it ships. In devices, the difference between a good page and an unlawful one is often a single verb, so I write to the entry and show my working.

ISB alumnaAgency trained on Australian accountsNo regulator flags to dateTGA · Advertising Code 2021

06

06The alternatives

Why not just hire any copywriter?

Because most of them have never read an ARTG entry, and the entry is the whole job. Here is the honest comparison.

✗

An SEO agency

Ranks you for terms your intended purpose does not cover. They know Google. They have never opened the Advertising Code.

✗

A compliance lawyer

Keeps you legal and hands you copy no one reads. Safe and invisible is still invisible.

✗

A cheap freelancer

Copy that claims the device treats something. You save a few hundred dollars and hand your regulatory lead a rewrite.

✗

ChatGPT on its own

Fast, generic, no judgement. It will confidently write clinically proven to prevent, which is the claim that needs permission.

✓

A compliance-first copywriter

Compliant, ranks, quoted by AI, books demos. I do all four. And I personally watch every word, so you always know who is writing: me. Every page passes the 226-point GhostRank check first.

07

07The rules, in plain English

What can a medical device company say in its marketing?

Short version: whatever sits inside the intended purpose in your ARTG entry, said plainly, without a restricted representation. Here is how that plays out on a real product site.

✓ What you can say

Describe the device's intended purpose as it appears in the ARTG entry.
Explain what it measures or does, how it is used, and who it is for.
Present your evidence accurately, with the study and its limits.
Include the trade name and at least one accepted indication or intended purpose.
Say clearly which audience a page is written for.

vs

✗ What you can't say

Advertise a device that is not included in the ARTG.
Promote the device for a purpose outside its ARTG entry.
Make a restricted representation about a serious disease without permission.
Make a prohibited representation at all.
Leave a third-party comment on your channel making a claim you could not make.

Why does device marketing get rewritten so late, and so often?

Because the copy is usually written from the sales story, then checked against the ARTG entry at the end. It should run the other way. It is an offence to advertise to any person a medical device that is not included in the Australian Register of Therapeutic Goods, and it is prohibited to promote a device for a purpose outside its entry. The entry defines the intended purpose, and the intended purpose is the outer edge of every sentence marketing is allowed to write. Add the Therapeutic Goods Advertising Code 2021 on top, which has governed device advertising in its current form since the Code framework took effect, and there are also mandatory inclusions for advertisements other than labels, such as the trade name and at least one accepted indication or intended purpose.

How literally is the entry read? Very. On 19 September 2024 the Federal Court ordered Medtronic Australasia to pay $22 million, the largest penalty ever under the Therapeutic Goods Act, plus $1 million toward the TGA's legal costs. The company had supplied 16,267 units of a bone graft kit to 109 hospitals between 1 September 2015 and 31 January 2020. The kit was in the ARTG only for supply together with a separately packaged spinal cage, and the entry did not permit supply without it. There were no reports of injury or harm. The company admitted it had been aware of the concern as early as 2009. That was a supply case rather than an advertising one, and that is precisely why it is worth knowing. The gap between an ARTG entry and what a business actually does is enforceable on its own, with no patient ever harmed.

Two more things shape device copy in 2026. First, audience matters. The rules that bite hardest govern advertising directed to the public, and communications to health professionals sit under different requirements. Most device websites do both on the same page, which is where the trouble starts. Second, social media. The TGA updated its social media advertising guidance on 6 November 2025. Responsibility rests with whoever controls the account, and that includes third-party comments on channels you control. Influencers promoting therapeutic goods are advertisers under the Act, and a manufacturer is responsible for what an influencer acting on its behalf posts. Whether something counts as advertising depends on its overall effect, not on how it is labelled, so content framed as education or professional discussion can still be advertising. Start with the Therapeutic Goods Advertising Code 2021, the guidance on advertising software-based medical devices, and the social media guidance. Penalties reach $1,565,000 for an individual and $15.65 million for a body corporate.

the unfair advantage

A tool no other copywriter has. Yours, on the house.

GhostRank is my proprietary 226-point audit. It checks how a page ranks on Google, how it reads to AI search, and where it breaks the advertising rules. Device companies pay $1,500 for this audit on its own. When you hire me, every page runs through it before it ships. You never pay for it.

$1,500$0 The audit device companies pay $1,500 for. Free with every project.

0

Checks per page

3

SEO · AI · rules

A GhostRank audit scorecard showing an overall score and signal coverage

GhostRank risk register, issues ranked by severity — Risk register

GhostRank prioritised fix roadmap — Fix roadmap

GhostRank page-by-page score cards — Page cards

08

08Pricing

Flat quotes. Priced to your scope.

✓ The GhostRank Audit, $1,500. Every flag comes with a rewrite.

Option one · A few pages

from $2,490 AUD

Five pages for $2,490. Ten pages for $4,390.

Strategy, writing, compliance check
Written for Google and AI search
Two rounds of edits

Start a conversation

Option two · The whole project

Custom quote

Your full site. Ads and articles, if you want them.

Every page, one voice
Strategy included
One flat quote, upfront

Start a conversation →

The GhostRank Audit is $1,500 and covers up to 20 pages, with a suggested compliant rewrite for every flag it raises. Ongoing SEO is $2,000 a month on a six month minimum. No hourly billing, on any of it.

A note from me

Dear founder or marketing lead,

You have a device that works, a regulatory lead who says no, and a launch date that has already moved twice.

I have seen that loop from the inside. Marketing writes the page from the sales story. Regulatory reads it and strikes out the verbs. Marketing rewrites it into something so cautious that nobody can tell what the device does. Everyone is frustrated, and the page still is not live.

The fix is not more rounds. It is writing from the ARTG entry in the first place. The intended purpose you registered is the outer edge of what the copy can claim. Start there and the page comes back approved instead of bleeding red. It also reads better, because specifics about what the device measures, how it fits the workflow, and what the evidence shows are more persuasive than clinically proven ever was.

The stakes are not theoretical. The largest penalty in the history of the Therapeutic Goods Act, $22 million, came out of a gap between an ARTG entry and what a company actually did. Nobody was harmed. The gap was enough.

I read the entry before I write a word, and I hand back a note on why each claim sits inside it. That note is what makes your regulatory review fast. No delivered work of mine has been flagged by a regulator to date.

So let me take the words off your plate. Written to the entry. Built to sell. Approved on the first pass, or close to it.

You built the device. Let me handle the words.

Amisha

Amisha Sharma · Compliance-first copywriter

P.S. Just send me a message today. We can get together and see how I can help.

09

09Questions

The ones device teams ask.

Can we advertise a device that is not yet in the ARTG?+

No. It is an offence to advertise to any person a medical device that is not included in the Australian Register of Therapeutic Goods. This catches pre-launch pages, coming soon announcements and pilot programs more often than people expect. If the product is not in the ARTG, the page cannot promote it to the public.

What does intended purpose actually limit?+

Everything the copy claims. The ARTG entry defines the intended purpose, and it is prohibited to promote a device for a purpose outside that entry. In practice that means the verbs. Monitors, measures and assists are different claims from treats, prevents and cures, and only the ones inside your entry are available to you.

Was the Medtronic case about advertising?+

No, and that is why it is worth knowing. On 19 September 2024 the Federal Court ordered Medtronic Australasia to pay $22 million, the largest penalty ever under the Therapeutic Goods Act, plus $1 million toward the TGA's costs, over 16,267 units of a bone graft kit supplied to 109 hospitals between 2015 and 2020 in a way the ARTG entry did not permit. There were no reports of injury or harm. The lesson for copy is that the gap between an ARTG entry and reality is enforceable on its own.

Are the rules different when we market to clinicians instead of consumers?+

Yes. The advertising rules that bite hardest govern advertising directed to the public, and communications to health professionals sit under different requirements. The practical problem is that most device websites mix both audiences on the same page, so material intended for clinicians ends up publicly accessible and gets read as consumer advertising. Separating them properly is a copy and structure job.

Do the rules apply to software and apps?+

If the software meets the definition of a medical device, yes. The TGA publishes specific guidance on advertising software-based medical devices, and this is the lane a lot of healthtech and diagnostics companies discover they are in only after their marketing site is built. The intended purpose in the entry governs the claims in exactly the same way.

Who is responsible for what an influencer or a reseller posts?+

You are, in most practical cases. The TGA's updated social media advertising guidance, released on 6 November 2025, puts responsibility with whoever controls the account or platform, including third-party comments on channels you control. Influencers promoting therapeutic goods are advertisers under the Act with the same obligations, and the manufacturer is responsible for what an influencer acting on its behalf posts.

Can we say clinically proven?+

Only if the evidence supports the exact claim and the claim sits inside your intended purpose. Even then it is usually weaker copy than describing the study, the population and the result. Buyers who run procurement respond to specifics. A vague proof claim invites the one follow-up question you did not want.

Will compliant device copy still convert?+

Yes. The claims you have to drop were adjectives. What replaces them is the detail a clinical buyer actually wants: what it measures, how it fits the workflow, what the evidence shows and where the limits are. That detail is also what Google and AI search reward, so the same rewrite usually improves visibility.

Can you work with our regulatory affairs team?+

Yes, and it makes everything faster. I write from the ARTG entry, then hand back a short note on why each claim sits inside it. Your regulatory lead reviews reasoning rather than reverse-engineering intent, which is what turns three rounds of edits into one.

What does medical device copywriting cost?+

Prices are fixed and published. The GhostRank Audit is $1,500 for up to 20 pages, and every flag comes with a suggested compliant rewrite. Website copy packages are $2,490 for five pages and $4,390 for ten. Ongoing SEO is $2,000 a month on a six month minimum. There is no hourly billing and no surprise invoice.

Do you guarantee it's compliant?+

I write to the current Therapeutic Goods Act requirements and the Advertising Code 2021, and I add a short note on why each claim is safe. That note makes your regulatory review fast and cheap. No writer can promise a regulator's final view. No delivered work of mine has been flagged by a regulator to date.

Device copy that stays inside your ARTG entry.

Same device. Two ways to write it.

Your ARTG entry is the script. Marketing keeps writing a better one.