In this guide · 7 sections
- 01HSA licences a medical device distributor needs
- 02Product registration by risk class
- 03HSA advertising rules that apply to your website
- 04How to build a gated B2B catalogue with price on request
- 05What hospital and clinic buyers expect from your systems
- 06Do it yourself or get help?
- 07Frequently asked questions
Short answer
Import and wholesale need an HSA dealer's licence, and Class B, C and D devices need product registration (Class A needs a product notification). On the website, keep 'professional use only' devices behind a login for qualified practitioners, and follow HSA's advertising principles for anything public.
HSA licences a medical device distributor needs
HSA regulates the import, manufacture, export and supply of medical devices. Its dealer's licence page sets out three licence types, all applied for through HSA's SHARE system.
| Licence | What it covers | Quality system evidence |
|---|---|---|
| Importer's licence | Bringing medical devices into Singapore | MDSAP, ISO 13485 or GDPMDS certificate and audit report |
| Wholesaler's licence | Wholesale supply (including export), supply for re-supply, commercial samples | Same options as importer |
| Manufacturer's licence | Making, packaging or labelling devices | MDSAP or ISO 13485 |
Two details matter for a distributor. Licensed importers also need a wholesaler's licence to supply wholesale. And HSA says a wholesaler's licence is not needed for supply to end-users, such as in a retail store. ISO 13485 and GDPMDS certificates must come from a certification body accredited by the Singapore Accreditation Council.
Product registration by risk class
Separately from your licence, each device needs to be on the market legally. HSA's registration overview explains that the route depends on the device's risk class, prior approvals from overseas reference agencies (such as Australia's TGA or EU notified bodies) and its safe marketing history.
- Class A (lowest risk): exempt from product registration, but you must submit a product notification in SHARE for Class A devices you manufacture or import.
- Class B, C and D: registration through a full, abridged, expedited or immediate route, depending on the conditions HSA sets out.
For the website, this means each product page should match what is registered or notified: the same device name, model and intended use. Selling an unregistered variant online is the same problem as selling it from a warehouse.
HSA advertising rules that apply to your website
HSA's advertisements and promotions page defines advertisement broadly: the internet, social media posts and reels, user endorsements, brochures, exhibitions and more. The advertiser is responsible for compliance.
For anything the public can see, HSA lists conditions a device advertisement must not claim to prevent, alleviate or cure. They include blindness, cancer, cataract, deafness, diabetes, epilepsy, hypertension, kidney diseases, paralysis, infertility and conception and pregnancy, among others. HSA's general principles also apply:
- Truthful, substantiated claims, with no unqualified superlatives such as 'the best'
- No endorsements or recommendations from healthcare professionals
- No claims of being 100% safe, side-effect free or a guaranteed cure
- No use of HSA's name or logo, or other firms' logos without written permission
- Comparisons only if scientifically proven and presented fairly
- Compliance with the Singapore Code of Advertising Practice
HSA's guidance document GN-08 on medical device advertisements and sales promotion gives the detail, including acceptable claims for Class A devices. This guide is general information, not legal or regulatory advice.
How to build a gated B2B catalogue with price on request
Most distributors end up with two layers: a public site that describes the company, brands and therapy areas, and a trade portal where verified buyers see full product details and prices. A practical setup looks like this.
Classify every product before it goes online
Tag each SKU by risk class, registration or notification status, and whether it is professional use only.
Keep the public layer general
Company profile, brands carried, product categories and contact routes. Avoid detailed claims for professional-use devices.
Gate professional products behind a verified login
Ask for the buyer's organisation, role and a licence or registration number, and approve accounts manually before access.
Use price on request or customer-specific pricing
Hospital and clinic pricing is usually contract-based. A request-for-quote form or tiered price lists per account fits better than public prices.
Attach documents buyers need
IFUs, product brochures approved for professional audiences, and certificates, downloadable only after login.
Review content changes before they go live
Have someone check new product pages and social posts against HSA's principles, and keep a record of approvals.
On Shopify, a gated catalogue usually means customer accounts plus, depending on your plan, Shopify B2B features or an app to hide prices from guests and set price lists per account. Our guide to Shopify store costs in Singapore covers the plan and app costs involved.
What hospital and clinic buyers expect from your systems
Institutional buyers judge a supplier partly on admin. A few things make you easier to buy from:
- E-invoicing. GST-registered businesses are being brought onto InvoiceNow under IRAS's requirement, and non-registered firms can join voluntarily when buyers or government agencies ask for e-invoices. Our InvoiceNow (Peppol) set-up guide explains the steps.
- Clear licence information. Show your company name and UEN, and keep your HSA licence details ready for buyer due diligence.
- Recall and safety contacts. A named contact and process for field safety notices and adverse event reports, which HSA also covers in its post-market requirements.
- PDPA-compliant forms. Trade sign-up and enquiry forms collect personal data; see our guide to a website privacy policy and cookie consent.
If you also sell lower-risk products to consumers, our guide on licences to sell online in Singapore covers health products and other regulated categories.
Do it yourself or get help?
The regulatory work, licences, registration and claim review, stays with your regulatory affairs person or consultant. The website side is where a builder helps: separating public and trade content, building approvals for trade accounts and connecting invoices to InvoiceNow.
Medical device website checklist
Our Business Website package (S$1,490) builds the public company site; for an online catalogue on Shopify, see the Shopify Store package (S$1,890); trade-account gating is scoped on top. InvoiceNow (Peppol) Setup (S$190) connects your accounting software so you can send e-invoices.
Frequently asked questions
If you import medical devices, you need an importer's licence, and to supply them wholesale you need a wholesaler's licence. HSA says a wholesaler's licence is not required for supply to end-users, such as in a retail store. The devices themselves also need registration, or a product notification for Class A devices.
HSA's rules focus on advertising claims and audience rather than prices. The bigger issue is that 'professional use only' devices may only be advertised to qualified practitioners, so their pages, prices included, should sit behind a verified trade login. Many distributors use price on request because institutional pricing is contract-based anyway.
No. HSA's general principles say medical device advertisements should not carry endorsements or recommendations by healthcare professionals. User reviews used in advertising are allowed only if they reflect a typical user's experience and the device's intended purpose, and are not framed to make fictitious characters look like real people.
No. Class A devices are exempt from product registration, but HSA requires a product notification in SHARE for Class A devices you manufacture or import. Dealers handling only Class A devices still need licences and can submit a declaration of conformity to a quality management system instead of a certificate.
Yes. HSA's definition of advertisement includes social media platforms, such as videos, reels, still posts and user endorsements, as well as the internet in general. The same claim restrictions and general principles apply as for print, so review posts with the same care as your website.