Selling medical devices on Shopify. Payments is the hard part.
Medical devices face the strictest underwriting in payments: regulators define what you can sell, and processors demand proof you meet their standards before touching a transaction.
Move all of it into a new store, from $247
One-time packages, no per-record metering, no quotes. The order form unlocks the moment you pay, counts are matched against your old store, and the entire migration then runs a second time — the second pass has to create nothing.
And then there is the part that actually loses businesses
If you do need a new store, the payments problem turns out to be the easy half. This is what is sitting in your current store right now, and what happens to each piece when someone tries to move it by hand:
Why this category in particular
Medical device data is dangerous to move by hand because regulatory compliance metadata lives in metafields: FDA clearance references, intended-use codes, contraindication warnings, and device-classification codes are all stored as custom fields that a CSV export cannot carry. If these fields are lost or point to the wrong product during migration, your store renders with incomplete or missing regulatory information — and a customer injured by an unmarked contraindication creates liability that no processor will touch. The compliance chain must survive the move intact.
| What you own | How much of it | What breaks doing it by hand | What we do instead |
|---|---|---|---|
| Product images | 3,600images≈ 15 hrsbulk re-upload, ~15 sec each | By handthe CSV carries image URLs and alt text, but they point at your OLD store's CDN — so the moment the old store goes, every image 404s. Re-upload and Shopify appends a dedupe suffix to the filename, which breaks every theme section and product description that referenced the original URL | Automatedevery file re-uploaded through the API with its alt text and variant attachment intact, its content type preserved so image-restricted fields still accept it, and every reference to the old URL rewritten |
| Product descriptions | 450descriptions≈ 2 hrsone pass to repair inline image links — the CSV carries the text | By handdescriptions are full of inline images and links pointing at the old store's CDN. Paste them into the new store and the text survives perfectly while every embedded image quietly dies — which you usually discover from a customer, not from a report | Automatedbodies copied verbatim, then a second pass rewrites every source-CDN URL inside them to the re-uploaded file on the new store |
| Product attributes & variants | 1,350variants≈ 45 minthe CSV carries these; the time is verifying option order | By handoption ORDER is part of the product's identity. Rebuild "Size, Colour" as "Colour, Size" and every theme swatch, saved customer URL and app that keys on variant position breaks — silently, because the product page still renders | Automatedvariants upserted by SKU with option names and order preserved, so swatches, deep links and app data keep working |
| Metafields & metaobjects | 6,300metafields≈ 42 hrsonly the reference, JSON and metaobject fields, ~1 min each | By handthe product CSV carries simple text and number metafields — but not metaobjects, and not reference or JSON types, which is exactly where app data and theme content live. Reference fields are the real trap: copy the value and it still points at objects in the OLD store, so the page renders and the custom block is silently empty | Automatedwritten in dependency order after their targets exist, with embedded references re-pointed at the new store's objects — and any value whose reference cannot be resolved is dropped rather than written broken |
| SEO data & redirects | 600records≈ 3 hrsredirects one at a time, plus a handle audit | By handany handle that changes becomes a dead URL with no redirect, and existing 301s are not in the product CSV at all. Years of accumulated ranking and backlinks end up pointing at pages that no longer resolve — the most expensive thing on this page to get wrong, and the slowest to notice | AutomatedSEO titles, meta descriptions and handles carried across, and every existing 301 recreated, so nothing that used to rank starts 404ing |
| Your custom theme | 1theme≈ 6 hrs2–10 hrs depending on how customised it is | By handa theme is not just its files. The settings, section content and block ordering are stored against the store, so a file copy gives you the layout and none of the content. Hardcoded asset URLs and tracking snippets also still point at the old store | Automatedyour live theme pulled and pushed as-is, then scanned for tracking snippets and hardcoded URLs that need re-pointing |
| Product videos | 25videos≈ 2 hrsre-upload and re-attach, ~4 min each | By handthe product CSV does not carry video or 3D media, so every one is a manual re-upload. They also cannot be pulled straight from a remote URL — the bytes have to be downloaded and staged first, and a wrong content type lands the file as a generic attachment that media-restricted fields then reject | Automatedvideo bytes downloaded, staged through a proper upload target, re-attached to the right product, and verified as processed rather than silently failed |
| Customers | 2,800customers≈ 2 hrsCSV import, then cleaning up the rows that fail | By handthe importer works, but marketing consent is the exposure: the CSV carries the current opt-in state and NOT the timestamp or source behind it. Re-opting someone in is a compliance breach, dropping them burns list revenue you paid for, and you cannot prove which happened afterwards. Default-address designation is also lost | Automatedcustomers upserted by email with every address, the default-address designation, and email and SMS consent states and timestamps preserved exactly as they were |
| Order history | 4,200orders≈ 8 hrsa paid third-party importer, plus a day of mapping and reconciliation | By handShopify's own CSV importer cannot create orders at all, so the hours here assume you buy a third-party importer — key them in by hand instead and 9,400 orders is closer to 390 hours, which is why nobody does that and why order history is simply abandoned in most DIY moves. Then support cannot answer a warranty claim, repeat-purchase segments are empty, and every returning-customer flow starts from zero. Getting the mapping wrong duplicates orders or re-dates them to today, and both are worse than not importing at all | Automatedfull order history recreated through the API with line items, properties, customers re-associated, original dates and tracking numbers intact |
| Navigation menus | 3menus≈ 1 hrsabout an hour to rebuild and relink them all by hand | By handmenu items store resource IDs, not paths, so nothing about them is portable — every link has to be re-pointed at the equivalent collection, page or product on the new store | Automatedmenus rebuilt with their nesting, and every item re-pointed at the equivalent object on the new store |
| Discount codes | 45discounts≈ 1 hrsabout 1 hr via the discount CSV, or ~3 hrs rebuilt by hand | By handthe discount CSV covers basic codes, but automatic discounts, quantity breaks and combination rules are not in it and have to be reconstructed by hand. A subtly wrong rule is worse than a missing one, because nobody notices until it has been over-discounting for a fortnight | Automateddiscounts recreated through the API with their rules, usage limits and dates intact, including automatic and free-shipping types |
| Blogs & pages | 30articles & pages≈ 2 hrsrecreated one at a time, ~4 min each | By handno CSV route for either. Articles also have no SEO fields of their own — their title and description tags live in metafields — so a hand-rebuilt blog loses its SEO even when every word of the text is right | Automatedarticles and pages recreated with authors, tags and publish dates, their SEO written to the metafields Shopify actually stores it in, and inline image URLs rewritten |
| Apps & app data | 12apps≈ 12 hrsabout 1 hr per app to reinstall, reconfigure and re-test | By handmost app data lives in metafields on your products and customers, so reinstalling the app gets you an empty app: reviews gone, subscription plans gone, loyalty balances gone, bundles gone. Flows and automations have to be rebuilt by hand and re-tested, and anything with its own billing has to be re-subscribed | Automatedthe metafield data your apps rely on migrates with the products and customers it hangs off, so a reinstalled app finds its data waiting instead of an empty store |
See these numbers for YOUR store, free
Those are typical figures for this category. The read-only scan counts what is actually in your store, so you know the real scale before you decide anything. No card, and it works even if your storefront is already offline.
▶ Run the free demo scanWhy it happened — specifically for medical devices
Stripe, which underwrites Shopify Payments, restricts prescription-only and regulated medical devices outright. The primary trigger is device class and registration status: a Class I wellness device is ordinary retail, but Class II or higher devices require regulatory clearance evidence. The secondary trigger is efficacy claims — any statement that your device diagnoses, treats or prevents a condition reads to a reviewer as an unproven medical claim, which moves you from restricted to prohibited. Japan additionally restricts health instruments specifically, regardless of class.
Rule out the easy fix first — then deal with the real one
There is no documented Shopify route for medical devices, and the honest reason is that Shopify Payments cannot take them at any class level without a separate underwriting conversation that Stripe controls entirely. What merchants try first is connecting through Shopify's high-risk gateway integrations and hoping the device classification does not come up — it always does. The real path is to find a high-risk acquirer willing to take your specific device class, which means proving your regulatory status upfront: FDA 510(k) clearance, CE marking, or a genuine wellness exemption. That conversation happens outside Shopify.
It only helps if all of these are true:
- Your device must have valid regulatory clearance or a documented exemption for your jurisdiction.
- You must remove any claim that your device diagnoses, treats, prevents or cures a condition.
- You need a high-risk merchant account before connecting any gateway; Shopify integration alone does not secure one.
- Your processing history must show no prior payment declines or chargebacks related to device claims.
- You cannot process if your device is restricted in Japan and you ship there.
If any one of them does not hold, you are where everyone else on this page is: you need a store built around a gateway that will actually accept you — and everything you have built has to move into it without losing the catalog, the customers, the order history or the rankings.
What you actually have to fix
Underwriters do not change their minds because you asked. They change them because the facts changed. For medical devices, these are the facts that move the decision:
Obtain and document your device's regulatory clearance
This is the highest-yield fix because without it you cannot move forward with any acquirer. If you are selling in the US, you need either an FDA 510(k) clearance letter for your specific device and intended use, or a genuine Class I wellness exemption backed by a legal opinion. If you sell internationally, you need CE marking or equivalent. Gather the actual clearance documents, not a screenshot or a claim — acquirers ask for originals and will verify them.
Remove every medical and efficacy claim from your store
Efficacy claims are the most common decline trigger. Audit your product descriptions, your FAQs, your email sequences and your ads for any statement that your device diagnoses, treats, prevents, cures or manages a condition. This includes indirect claims: 'supports joint health' or 'promotes better sleep' read as therapeutic. Switch to structure-and-function language only — what the device does mechanically, not what it does to the body.
Identify a high-risk acquirer before applying through any gateway
Do not assume that connecting a gateway on Shopify will unlock payment processing. High-risk acquirers for medical devices publicly advertise they take this category, but they run their own underwriting after you apply — they will ask for your clearance documents, your product claims, your processing history and your chargeback data. Start conversations with acquirers who explicitly mention medical devices. Have your regulatory documents ready before you reach out.
Prepare a clear business plan for your underwriting conversation
Acquirers want to understand your customer, your distribution and your claim-handling process. Write a one-page summary of who you sell to, how you acquired your customers so far, what your return and chargeback rates have been, and how you handle customer disputes or product returns. If you have been declined before, explain what changed. Honesty here outweighs a polished pitch.
What underwriting will ask you for
- FDA 510(k) clearance letter or CE certification for your specific device model and intended use
- Product labeling and instructions for use, showing no efficacy or medical claims
- A completed product classification worksheet mapping your device to its FDA class or equivalent regulator
- Supplier or manufacturing agreement proving you are authorised to sell this device
- Your privacy and data-handling policy, particularly if your device collects health information
- Recent bank statements showing transaction history and chargeback ratio
- A detailed business plan describing your target customer and distribution method
Getting underwritten for medical devices
High-risk acquiring is an entire industry that exists for businesses Stripe declines, and several of them publicly underwrite medical devices. What none of them will tell you up front is the number that actually matters: what your business gets offered, once they have seen your volume, your claims and your history. Rate, reserve and settlement terms vary enormously between applicants in the same category.
Get real quotes from high-risk processors that accept medical devices
Six taps and three details. We put it in front of the high-risk acquirers that actually underwrite your category and come back with what they will offer you — rate, reserve and settlement terms — so you are comparing real numbers instead of cold-emailing brokers for a fortnight.
New company, new merchant account — the honest version
A new legal entity does not help you in this category. If you have been declined for medical device processing, a new company does not reset your underwriting risk — it simply restarts the same clearance and claims review. MATCH, the payment industry's decline database, follows the person behind the business for five years. A new entity structure without addressing your regulatory status or efficacy claims will result in the same decline.
What a MATCH listing actually is
- A listing lasts five years from the date it is added, then ages off automatically. There is no performance-based early release.
- It lists the principals — name, tax ID, address — as well as the business, which is exactly why a new company with the same owners is not a fresh start.
- Only the acquirer that listed you can remove it, and only in two situations: the listing was made in error, or the reason code was PCI non-compliance and you have since become compliant.
- Reason codes are specific and they matter: excessive chargebacks reads very differently to an underwriter than laundering or illegal transactions.
- It is not a card-network ban. High-risk acquirers knowingly board MATCH-listed merchants — at worse rates, with larger reserves, and with volume caps.
- You are entitled to ask the terminating acquirer whether you were listed and under which code. Do that before you apply anywhere else, because you will be asked.
What a new merchant account requires
The entity
Formation documents, EIN or company number, and a business bank account in the company's name with a voided cheque or statement.
The people
Government ID and personal details for every beneficial owner. Underwriting is done on the humans as well as the company — which is why a new company with the same owners does not present as a new applicant.
The history
Three to six months of processing statements if you have any, plus bank statements. A prior termination is disclosed here. Concealing it is the fraud, not the termination.
The website
A live, compliant storefront: clear billing descriptor, contact details, terms, refund and shipping policies, SSL, working checkout, and no claims that contradict your category.
The product
Supplier agreements, certificates of analysis for anything ingestible, licences for anything regulated, and evidence of how you fulfil.
The numbers
Expected monthly volume, average order value and your chargeback history. Understating volume to get approved is a fast route to a frozen account.
A MATCH screen
Run against both the business and its principals. This is the step that decides the application, and there is no way around it — only through it, by disclosing and finding an acquirer who underwrites anyway.
If you do need a new entity, these are the routes people actually use
Costs and timelines below are indicative and go out of date — treat them as a starting point, not a quote.
Wyoming is the default for an ecommerce LLC: ~$100 to file, ~$60/yr to maintain, no state income tax and strong owner privacy. Delaware is the investor standard and costs $300/yr in LLC franchise tax for governing law most DTC stores will never rely on. If you are not raising money, Wyoming is almost always the right answer.
Move everything for a fixed price
One-time packages — no per-record metering, no quotes. The migration order form unlocks the moment you pay, and the whole migration re-runs a second time before any cutover.
How the migration runs
- Book & pay — fixed price, secure Stripe checkout. The order form unlocks immediately after payment.
- Submit your stores — domains and details in the order form; then provide revocable API tokens in your customer area (we never ask for your Shopify password).
- We migrate everything — your live store keeps selling throughout; it is only ever read from.
- Verified twice — the entire migration re-runs and must change nothing; you get the count-matched verification report before any cutover.
See exactly what would move — before you spend anything
The demo scan connects read-only to your current store and counts every product, variant, image, customer, order and metafield in it, then tells you what a migration would carry across. It never writes to your store, and it works even if your storefront is already offline.
▶ Run the free demo scanIf it has already happened
Whatever Shopify has actually done — disabled the gateway, opened a review, frozen your payouts, closed the store — the recovery differs. Find the one that matches your notice:
Shopify Payments Disabled for a Medical-Device Store? How to Recover
Shopify Payments disabled — what it means specifically for medical devices.
Shopify Payments Account Under Review for a Medical-Device Store?…
Account under review — what it means specifically for medical devices.
Shopify Payments Not Available for a Medical-Device Store? How to…
Application rejected — what it means specifically for medical devices.
High Chargeback Rate Warning for a Medical-Device Store? How to…
High chargeback rate — what it means specifically for medical devices.
High-Risk Payment Gateway for Shopify for a Medical-Device Store?…
Finding a high-risk payment gateway — what it means specifically for medical devices.
Migrate a Shopify Store to a New Account for a Medical-Device Store?…
Migrating to a new Shopify store — what it means specifically for medical devices.
New Company for a New Merchant Account for a Medical-Device Store?…
New company, new merchant account — what it means specifically for medical devices.
Shopify Payouts on Hold for a Medical-Device Store? How to Recover
Payouts on hold — what it means specifically for medical devices.
Shopify Payments Prohibited Business for a Medical-Device Store? How…
Prohibited business type — what it means specifically for medical devices.
Shopify Payments Terminated for a Medical-Device Store? How to Recover
Shopify Payments terminated — what it means specifically for medical devices.
Shopify Store Suspended for a Medical-Device Store? How to Recover
Shopify store suspended — what it means specifically for medical devices.
Shopify Payments Rolling Reserve for a Medical-Device Store? How to…
Rolling reserve imposed — what it means specifically for medical devices.
How to Reactivate Shopify Payments for a Medical-Device Store? How…
Appealing a Shopify Payments decision — what it means specifically for medical devices.
Frequently asked
Which payment gateway will process medical devices?
The gateway is not the bottleneck — the merchant account is. Several acquirers publicly advertise high-risk medical device processing and integrate with gateways Shopify supports natively, but which one will take your application depends on your device class, your regulatory clearance, your product claims and your history. Authorize.net on a high-risk MID, PaymentCloud, Soar Payments and Easy Pay Direct are known to underwrite in this space, but approval is never guaranteed. Start by preparing your regulatory documents and removing efficacy claims, then approach acquirers directly with a clear application.
What reserve should I expect?
Medical device merchants commonly report reserves of 5–10% rolling, held for 90–180 days. The exact reserve depends on your device class, your clearance status, your transaction volume and the acquirer's risk appetite. Class II devices with solid regulatory documentation often see the lower end; higher-risk classifications or new merchants may see the upper end. Ask any acquirer for their reserve policy before you commit.
Will my product metafields survive a store migration?
Shopify's native CSV export cannot carry metafields at all — not your FDA clearance references, not your device-class codes, not your contraindication warnings. If you migrate by hand, those fields vanish and must be re-entered manually, which is labour-intensive and error-prone on a catalogue of hundreds of devices. A full API-backed migration preserves every metafield intact, which is why compliance-heavy categories like medical devices are the highest-risk candidates for manual moves.
Can I start selling if I do not have FDA clearance yet?
No. Stripe and high-risk acquirers will not process a device without regulatory clearance or a documented exemption for your jurisdiction. If you are still in the FDA review process or pursuing a 510(k), you cannot legally take payments until clearance is granted. Attempting to process before clearance invites processor decline, chargeback exposure and regulatory action. Wait for the clearance letter before building your Shopify store.
Move everything, verified twice, from $247
Pick a package and the migration order form unlocks immediately. Your existing store is only ever read from — we never write to it, so nothing you still have can be made worse.