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November 16, 2025
Approximately 5 minutes
Medical Device License Maintenance: Annual Fees and Change Notifications
Singapore Medical Device License Maintenance: Annual Fees and Change Notifications
For manufacturers to maintain market access and comply with the Health Sciences Authority (HSA) regulations in Singapore, they must adhere to specific requirements for license maintenance, which includes annual fees and mandatory reporting of product or administrative changes.
Annual Retention Fees
Registered medical device listings on the Singapore Medical Device Register (SMDR) do not expire as long as the annual retention fee is paid and the product remains the same.
| Device Class | Annual Listing Fee (SG$) |
|---|---|
| Class B | S$39 |
| Class C | S$67 |
| Class D | S$134 |
HSA Change Notifications (Registration Modification)
Any changes to the product from the time of original registration must be approved by the HSA via a Registration Modification (Change Notification) prior to importing the modified product. HSA's guidance for these changes is detailed in GN-21.
The four types of changes requiring approval are:
- Administrative Changes: Affecting administrative documents and information submitted during registration (e.g., changes to the Registrant's address).
- Review Changes (Class B): Changes affecting the safety, quality, or efficacy of Class B devices, or the addition of new models/changes to indications for use.
- Technical Changes (Class C & D): Changes affecting the safety, quality, or efficacy of Class C and D medical devices.
- Notification Changes: All other changes, including removing device particulars publicly published on the SMDR listing. These can often be bundled together in one application.
Timelines and Fees for Change Notifications
| Device Classification | Change Type | Review Time | Fee (SG$) |
|---|---|---|---|
| Class B | Administrative | 30 days | S$560 |
| Class B | Review | 45 days | S$560 |
| Class C | Administrative | 30 days | S$560 |
| Class C | Technical | 75 days | S$1,890 |
| Class D | Administrative | 30 days | S$560 |
| Class D | Technical | 90 days | S$3,120 |
Note: Changes to Class D devices that contain a registrable drug do not have specified timelines and are estimated on a case-by-case basis by the HSA.
Changes Requiring a New Registration
Certain substantial changes do not qualify for a Change Notification and necessitate the submission of a completely new product registration application:
- Change in Risk Classification of the device.
- Change in Intended Use of the device.
- Change of the Registrable Drug where it plays a secondary role in a combination device.
- Addition of a Model that does not fulfill the Grouping Criteria outlined in the HSA Guidance Notes.
- Addition of Medical Devices with different proprietary names that are not permitted to be grouped under the existing listing.
The Registrant (License Holder) is responsible for ensuring all modifications are properly assessed and approved by the HSA before the changed product is imported. Failure to do so may result in the suspension or cancellation of the device listing.
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