The Dual Obligation Model
One of the most distinctive features of Singapore's medical device regulatory framework is that two separate and parallel obligations must both be satisfied before a medical device can be lawfully supplied in Singapore:
- Product registration — the device must appear on the Singapore Medical Device Register (SMDR), or for Class A devices, a product notification must have been submitted.
- Dealer's licence — the entity manufacturing, importing, or wholesaling the device must hold a current dealer's licence for that activity.
Neither obligation substitutes for the other. A registered device supplied by an unlicensed dealer, or a licensed dealer supplying an unregistered device, is non-compliant in both cases.
Why Singapore works this way
Most other frameworks fold dealer obligations into a single product-centred authorisation. Australia's ARTG, for example, names the sponsor as the accountable party; Health Canada's device licence names the manufacturer. Singapore deliberately separates the two to:
- Ensure accountability at the product level (the registration) and the supply chain level (the licence) independently;
- Allow flexibility in commercial arrangements — the registrant and the licensed dealer do not have to be the same company;
- Enable HSA to take action against non-compliant dealers even where the product registration itself is in order, and vice versa.
Product registration in summary
| Feature | Detail |
|---|---|
| What it covers | The specific device, its intended purpose, class, and the conditions of registration |
| Who holds it | The registrant — must be a Singapore-registered entity (ACRA-registered) |
| Register | Singapore Medical Device Register (SMDR) |
| Portal | SHARE |
| Class A | Exempt from registration; product notification required instead |
| Ongoing obligation | Change notification before making changes; annual charges may apply |
Dealer's licence in summary
| Feature | Detail |
|---|---|
| What it covers | The company's authorisation to manufacture, import, or wholesale medical devices |
| Who needs it | Any entity manufacturing, importing, or wholesaling in Singapore |
| Types | Manufacturer's licence / Importer's licence / Wholesaler's licence |
| Portal | SHARE |
| QMS requirement | ISO 13485-aligned QMS required for all licence types |
| GDP requirement | Good Distribution Practice compliance required for importers and wholesalers |
| Audit | HSA-recognised Medical Device Auditor must assess QMS before licence is granted |
How the two obligations interact — a worked example
Consider an overseas manufacturer (Company A, based in Germany) whose Class C device is being distributed in Singapore by a Singapore company (Company B):
| Step | Who does it | What they do |
|---|---|---|
| Product registration | Company B (as registrant) | Submits registration application via SHARE, citing CE marking from EU NB for abridged route |
| Dealer's licence — import | Company B (as importer) | Applies for importer's dealer's licence; gets QMS audited by HSA-recognised auditor |
| Dealer's licence — manufacture | Company A | No Singapore dealer's licence required — overseas manufacturer is not dealing in Singapore; their QMS is assessed as part of Company B's registration dossier |
| Supply to hospitals | Company B | Must ensure both registration is current and dealer's licence is current before supplying |
If Company B also re-sells to other Singapore distributors, it may also need a wholesaler's licence for that activity.
Common mistakes
Treating product registration as sufficient. Companies sometimes complete product registration and begin importing before obtaining a dealer's licence, or before their QMS audit is complete. Both must be in place before supply.
Forgetting the Class A notification. Class A devices are exempt from registration, but a product notification must still be submitted via SHARE by the manufacturer or importer. Supplying a Class A device without having submitted the notification is non-compliant.
Assuming the overseas manufacturer's licence covers Singapore. An overseas manufacturer's ISO 13485 certification or home-country licence does not provide a Singapore dealer's licence. The Singapore importer or wholesaler needs their own licence.