Dealer’s Licence: How to Combine the Three Types in Singapore

1. Key takeaways

Any company that imports, wholesales or manufactures medical devices in Singapore must hold a Dealer’s Licence issued by HSA. The licence is not one instrument but three activity-specific types: the Importer’s Licence, the Wholesaler’s Licence and the Manufacturer’s Licence. Under GN-02 R8, which took effect on 1 April 2026, each type covers a defined set of activities and carries its own quality management system evidence requirements. The three are applied for separately according to what the company actually does, and none of them substitutes for another. The application fee and the annual renewal fee are both SGD 1,110, the official review period is 10 working days, and each licence runs for 12 months. For a group planning a Singapore hub, the practical question is therefore not how many certificates a company needs in the abstract, but which regulated activities will be performed on the ground.

• Activity-based, not company-based. A licence authorises a defined activity, so the licence portfolio follows the activity list rather than the corporate chart.
• Three types only. Importing, wholesale supply (including export) and manufacturing each map to a separate licence.
• Fees are charged per licence. A new application and an annual renewal are SGD 1,110 each; a variation costs SGD 168.
• Review takes 10 working days. That clock covers HSA review, not preparation of the entity, CorpPass, SHARE access or QMS evidence.
• Validity is 12 months. Renewal is an annual obligation, supported by GIRO auto-renewal and reminder emails at 60, 45 and 30 calendar days before expiry.
• Audit reports are now mandatory. GN-02 R8 requires the audit report to be filed together with the ISO 13485, MDSAP or GDPMDS certificate for new applications and specified changes.

2. Legal basis

Part VI of the Health Products Act 2007 is the statutory foundation for dealer licensing in Singapore, and GN-02 R8, the Guidance on Licensing of Manufacturers, Importers and Wholesalers of MD, sets out how HSA administers it in practice. The guidance is explicit that a dealer’s licence is required where a company manufactures, imports or wholesales medical devices in Singapore. Applications, renewals and variations are handled through SHARE, which requires CorpPass credentials for the Singapore entity. The guidance also defines the boundary of each licence by reference to the activity performed rather than to the nature of the company holding it, which is why a single legal entity may legitimately need two or three licences at the same time.

HSA defines each licence by the activity it authorises.

Three boundary rules follow, and most licensing errors in Singapore arise from them: an importer’s licence holder still needs a wholesaler’s licence for wholesale supply; a manufacturer’s licence holder does not need one when supplying devices it manufactured itself; and no wholesaler’s licence is required to supply end users, such as a retail store.

3. Expert insights

Licences attach to activities, not to companies, and that is the core of the design. Clients often ask how many certificates their company needs. The better question is which activities the company will perform in Singapore. Three activities, namely import, wholesale and manufacture, correspond to a maximum of three certificates. A company that only imports and then sells to a hospital, which is an end user, needs an importer’s licence in principle. A company that imports and then wholesales to distributors needs both an importer’s licence and a wholesaler’s licence. Framing the question in corporate rather than operational terms is the most common reason a licence portfolio is over-built or, worse, under-built.

Export counts as wholesale. HSA states that the wholesaler’s licence covers supply by wholesale including export. A business that uses Singapore as a regional transit point and re-exports from there therefore needs a wholesaler’s licence, even though no device reaches a Singapore patient. This point is frequently overlooked by companies designing a regional headquarters in Singapore, because commercial teams view re-export as logistics rather than regulated supply. The licensing team should be involved early, before the warehouse lease is fixed around a structure that lacks the necessary licence.

GN-02 R8 turned the audit report into a compulsory attachment. R8, effective 1 April 2026, requires that new applications and specified variations be filed together with the audit report alongside the ISO 13485, MDSAP or GDPMDS certificate. This is one of the changes with the most direct effect on applicants in 2026, because the audit report is usually not held in-house. It sits with the certification body and has to be requested in advance. Building that request into the project timetable is now part of licence preparation, not an optional extra.

Validity is 12 months, so renewal is a recurring annual action. Under GN-02 R8 a licence is valid for 12 months. HSA offers automatic renewal for GIRO payment users and issues reminder emails 60, 45 and 30 calendar days before expiry. The reminders are not a control. Corporate email addresses change, staff leave, and shared mailboxes go unread. The reliable approach is to record the expiry date in the company compliance calendar with an internal owner and an internal escalation path, and to treat the HSA email as a secondary confirmation rather than as the trigger.

Special product categories require an additional licence. HSA makes clear that the import, supply and manufacture of abuse-of-drugs test kits require a controlled drugs licence under the Misuse of Drugs Act, in addition to the licence required under the Health Products (Medical Devices) Regulations. Companies in that category plan two regulatory tracks in parallel, with different authorities and different evidence. Discovering the second track after the dealer’s licence is granted is avoidable.

4. Practical recommendations

• List the activities before choosing the licence mix. Map import, wholesale, export, manufacture and retail separately, then assign one licence to each regulated activity that will actually occur.
• Treat import plus wholesale as two licences. Do not assume an importer’s licence carries wholesale rights.
• Request the QMS audit report early. It is a mandatory item under GN-02 R8 and typically comes from the certification body rather than from the manufacturer’s own files.
• Put renewal in the annual compliance calendar. Record the 12-month expiry, the internal owner and the escalation contact instead of relying on reminder emails alone.
• Screen special categories at the portfolio level. Test kits for drugs of abuse, for example, need a controlled drugs licence in addition to the medical device licence.
• Confirm the registered address and warehouse details before filing. Particulars must match the premises actually used; later changes should be filed as variations.

5. Verification checklist

• □ All Singapore activities listed, including export and contract manufacturing or repackaging
• □ The licence mix has been set by activity: import, wholesale, manufacture
• □ Export flows have been assessed against the wholesaler’s licence requirement
• □ QMS certificate and audit report are available, and the certification body is SAC-recognised
• □ Renewal dates recorded in the compliance calendar with an internal owner
• □ Special categories such as drugs-of-abuse test kits have been screened for additional licences
• □ SHARE and CorpPass access have been tested before filing

Regulatory information verified as of 26 October 2026. Source tiers: primary (Health Products Act 2007, Part VI); secondary (GN-02 R8, HSA dealer licensing page, HSA Quick Guide).

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Singapore. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with HSA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com