In Singapore, medium- and high-risk medical and in vitro diagnostic (IVD) devices must be registered with the Health Sciences Authority (HSA). Low-risk devices are not registered; they are instead listed on the local importer’s license in the HSA’s online system.
The Singaporean HSA medical device approval process explained
The chart illustrates the HSA approval process per device classification in Singapore and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a simplified overview of the main steps for registration of medium- and high-risk devices is provided here.
Determine the classification of your device according to the HSA’s classification rules.
Appoint a Singapore Registrant to manage your device registration and interact with the HSA on your behalf.
Determine the appropriate registration route for your device depending on risk class, device characteristics and marketing history.
Prepare an application dossier including all required documentation as applicable to the registration route for submission to the HSA.
Your Singapore Registrant submits the application electronically through the HSA’s online registration system and pays the application and evaluation fees.
The HSA reviews your application and may request additional information.
Upon HSA approval, they will inform your Registrant of the approved registration and list the device in the Singapore Medical Device Register (SMDR).
Log in to RAMS to view the chart
This is a condensed version of the steps outlined in the chart and only addresses the primary registration pathway in the market. You can obtain a detailed process chart and market reports for Singapore when you create your complementary Regulatory Affairs Management Suite (RAMS) account. Get your first chart for free when you create a RAMS account.