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Medical device registration. You will need to register your medical device before supplying it in Singapore. Find out how to complete your product registration here. Registration overview Understand the evaluation routes, fees and turn-around-times applicable when you register your medical device.
smdr@medics. Class A medical device database@medics. Please take note of the following on the submission of documents online: Attaching Files. Please refrain from opening multiple internet browser window tabs when accessing MEDICS.
Dec 4, 2019 · All medical devices registered with HSA are listed in the Singapore Medical Device Register (SMDR). Access Singapore Medical Device Register. Check with the retailer or dealer. Where Can I Obtain More Information? For more information on the regulation of medical devices in Singapore, you may refer to the HSA Website.
Oct 16, 2019 · This search enables you to get a listing of all registered Therapeutic Products in Singapore and their current approved Package Inserts. (PIs)/Patient Information Leaftlets (PILs). Note: Not all PIs and PILs are currently available online.
Sep 13, 2019 · This article was last reviewed on Friday, September 13, 2019. Find out if your Medicine/Medical Devices/Chinese Proprietary Medicines are registered/listed in Singapore.
Jul 1, 2022 · Registering Medical Devices in Singapore. Classification and Regulatory Pathways. The Health Sciences Authority (HSA) in Singapore closely follows GHTF guidelines to classify medical devices into Class A, B, C, and D, based on their risk levels, ranging from low to high.
Once approved, your product is listed in the Singapore Medical Device Register (SMDR) database. Singapore HSA authorized representative for medical devices. Foreign medical device manufacturers must appoint a Registrant to submit their device application and represent them to the HSA.
Registered medical devices are listed on the Singapore Medical Device Register (SMDR), which is publicly available on the HSA’s website. Which regulatory organizations are considered independent reference agencies by the HSA?
HSA has recently released the “Guidance on the Medical Device Unique Device Identification (UDI) System”. From 2022 in transitioning phases, HSA requires medical devices to be marketed in Singapore to be equipped with UDI-DI.
Jul 20, 2023 · The Health Sciences Authority (HSA) is the regulatory authority responsible for medical device registration in Singapore. HSA is a statutory board under the Ministry of Health (MOH) of Singapore. It is responsible for ensuring the safety, quality and efficacy of healthcare products in Singapore.
