Register medical devices with the HSA, using your existing approvals where you can.
Product registration routes, dealer licensing and the responsibilities of your local registrant.
Key facts
Pathways
- Class A: exempt from product registration, with dealer obligations
- Class B, C and D: product registration on the Singapore Medical Device Register
- Full, abridged and expedited evaluation routes depending on prior approvals from HSA's reference agencies
- Immediate registration for some lower-risk devices with qualifying approvals
What you will need
- Dossier in the ASEAN Common Submission Dossier Template (CSDT)
- Evidence of reference agency approvals where used
- Labelling and IFU
- Declaration of conformity
Sequence and decision points
- 01ClassifyApply HSA classification rules.
- 02Appoint a registrantA local company responsible for the registration.
- 03Choose the routeBased on prior approvals from reference agencies.
- 04SubmitCSDT dossier through the HSA online system.
- 05Register and supplyRegistration granted; dealers licensed.
Manufacturers provide ISO 13485 evidence. Importers and wholesalers need a dealer's licence and ISO 13485 or GDPMDS certification.
A Singapore-registered company must act as registrant and hold the product registration. Importers and wholesalers need dealer's licences.
Where MedoQi does not hold this role, we work with your appointed representative or a qualified partner.
HSA publishes target turnaround times and fees for each evaluation route. Routes that rely on reference agency approvals are shorter.
After market entry
- Adverse event reporting: 2, 10 or 30 days depending on severity
- Field safety corrective actions
- Change notifications for registered devices
- Annual retention of registration
How we help
- Classification and route selection
- CSDT dossier preparation
- Registrant coordination
- Change notification support
- Post-market reporting
Delivered through our model: assess, validate, remediate, submit, maintain. How we work
Common questions about Singapore
Summary information for orientation. Requirements depend on intended use, classification and device characteristics, and change over time.
Can MedoQi act as our Singapore registrant?
Registrant and dealer roles must be held by appropriately licensed local companies. We prepare the dossier and coordinate with your registrant, or help you appoint one.
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.