Registration overview of medical devices
Understand the evaluation routes, fees and turn-around-times applicable when you register your medical device.
Last updated 13 March 2026
Evaluation routes
Each device registration is done via a specific evaluation route. The evaluation route for your device depends on:
Risk classification of your device
Number of prior approvals given by our overseas reference regulatory agencies
Duration of safe marketing history for your device
The evaluation route of your device will determine the turn-around-time (TAT), fees and documents required for registration.
Check your device's evaluation route
Answer a few questions to find out the requirements for your device's registration route and whether you need to apply for a license.
Class A registration
Class A medical devices are exempted from product registration. However, you will need to submit a product notification application in SHARE for Class A medical devices that you manufacture or import.
Class B, C and D registration
Registration requirements
Refer to the table below for an overview of the evaluation routes for Class B, C and D medical devices.
A medical device without prior approval from any of our overseas reference regulatory agencies must undergo a full evaluation.
List of evaluation routes
Evaluation routes | Conditions |
|---|---|
Full Full (Priority Review Scheme) | No prior approval by any of our overseas reference regulatory agencies |
Abridged | Approval from at least one of our overseas reference regulatory agencies |
Expedited routes:
| ECR-1:
ECR-2/EDR:
|
Immediate Class B Registration (IBR) | Condition 1:
Condition 2:
|
Immediate routes, solely for standalone medical mobile applications:
|
|
Devices not qualified for expedited routes
Class C devices
The following medical devices cannot take the expedited Class C (ECR) route. These devices can only be registered via the full or abridged routes.
Hip, knee and shoulder joint replacement non-bioactive implants (e.g. non-bioactive metal/polymer implants)
Class D devices
The following medical devices cannot take the expedited Class D (EDR) route. These devices can only be registered via the full or abridged routes.
Active implantable devices (e.g. pacemakers, neurostimulators)
Implantable devices in direct contact with the central circulatory system or central nervous system
Hip, knee and shoulder joint replacement (e.g. bioactive implants)
Devices with a registrable drug in a secondary role
IVD assays (excluding IVD analysers) intended for HIV testing (screening and diagnosis) and blood/tissue donor compatibility testing
Overseas reference regulatory agencies
The approvals that qualify for the abridged, expedited and immediate evaluation routes are listed in the following table. These approvals must be on the same medical device labelled use that is intended for the Singapore market.
List of approvals that qualify for the abridged, expedited and immediate evaluation routes
Overseas reference regulatory agencies | Recognised approvals |
|---|---|
Australia Therapeutic Goods Administration (TGA) |
|
European Union Notified Bodies (EU NB) | For Class B
For Class C and D
|
Health Canada (HC) |
|
Japan Ministry of Health, Labour and Welfare (MHLW) |
|
US Food and Drug Administration (US FDA) |
|
NOTE: Class B, C and D medical devices that are classified and approved/cleared as Class I or Class II exempt in the above reference agencies do not qualify for the abridged, expedited or immediate routes based on these respective approvals.
Priority Review Scheme
The Priority Review Scheme provides the option for you to gain faster device registration and market entry for medical devices that are submitted to us through the full evaluation route.
Fees and turn-around-time
During the evaluation process, we will verify the information and supporting documents you submit, and will contact you if we need additional information from you via an Input Request (IR). Your device registration may be delayed if we do not receive all the necessary information in time.
Refer to medical device fees and turn-around-time for more information.
Prepare for registration
You can proceed to our registration guides once you have determined your product's risk classification and evaluation route.