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Before you can proceed to apply for eGIRO, you need to have access to e-Service, “HSA E-SERVICES: SINGAPORE HEALTH PRODUCT ACCESS AND REGULATION E-SYSTEM (SHARE). Please inform your company’s Corppass Admin to grant you the access via the Corppass portal .
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.
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.
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.
You may refer to the Singapore Medical Device Register (SMDR) for the device listing as registered by your company at: http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/MEDICS_e-Services/Singapore_Medical_Device_Register_smdr_MEDICS.html. ONLINE APPLICATION FORM FOR RETENTION. This online application form consists of 4 sections.
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.
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.
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.
