Registration Overview — the SHARE Portal
The Singapore Medical Device Register (SMDR)
Before a Class B, C, or D medical device can be supplied in Singapore, it must be registered on the Singapore Medical Device Register (SMDR). The SMDR is maintained by HSA and is publicly searchable via the Infosearch portal.
Registration confers legal permission to supply the device in Singapore under the conditions stated in the registration. It also establishes the registrant — the Singapore-registered entity accountable for the device's ongoing regulatory compliance.
The SHARE portal
All medical device registration applications are submitted through SHARE (Submission of Health products And Registration via E-portal):
hsa.gov.sg/medical-devices/e-services
SHARE handles:
- Class B, C, and D product registration applications
- Class A product notifications
- Change notification applications
- Dealer's licence applications
- Adverse event reports
- FSCA submissions
Before you submit — what you need
Before beginning a registration application, ensure the following decisions have been made:
| Pre-submission step | Resource |
|---|---|
| Confirm the product is a medical device | What is a Medical Device? |
| Determine classification (A/B/C/D) | How Classification Works |
| Determine grouping type | Device Grouping Overview |
| Determine evaluation route | Evaluation Routes |
| Check overseas reference agency approvals in hand | Overseas Reference Agencies |
The registration process — step by step
Step 1 — Pre-submission preparation
Compile the technical documentation required for the applicable evaluation route and device class. For full evaluation, this typically includes device description, classification justification, manufacturing information, design verification and validation, risk management documentation, clinical evidence, and labelling.
Step 2 — SHARE application submission
Submit the application through SHARE, selecting the correct product type, device class, grouping type, and evaluation route. Pay the applicable application fee.
Step 3 — Screening
HSA conducts an administrative screening to check that the application is complete and in the correct format. Applications that fail screening will be returned with reasons.
Step 4 — Evaluation
HSA evaluates the technical content of the application. During evaluation, HSA may issue Input Requests (IRs) requesting additional information or clarification. Applicants must respond within the timeframe specified in the IR.
The time taken to respond to IRs is not counted in HSA's published turnaround times (TAT) — IRs "stop the clock."
Step 5 — Registration decision
If the application is approved, HSA issues a Certificate of Registration and the device is added to the SMDR. If rejected, HSA provides reasons and the applicant may appeal.
Step 6 — Post-registration maintenance
Once registered, the registrant must:
- Submit a change notification before implementing any changes to the registered device;
- Maintain adverse event reporting and FSCA obligations;
- Ensure the registration is not cancelled or lapsed.
Fees and turnaround times
Fees and TATs vary by device class and evaluation route. Current fees and TATs are published on the HSA website:
hsa.gov.sg/medical-devices/fees