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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.
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 .
Annex B provides a guide on navigating the Singapore Medical Device Register (SMDR) for medical devices registered with HSA. Information on medical device license fees & charges can be found via this URL: http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/medical_devices/fees_and_ch arges0.html. Feedback/ enquiries.
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.
Aug 12, 2018 · Singapore’s Health Sciences Authority (HSA) is tasked with regulating drugs, innovative therapeutics, medical devices, and other health products to meet appropriate safety, quality, and efficacy standards, as well as contributing to the development of national drug policies.
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?
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.
This guidance document is intended to provide clarity on the regulatory requirements for Unique Device Identification (UDI) implementation in Singapore and the details on the steps to submit UDI information into the Singapore Medical Device Register (SMDR) and Class A Medical Device Database.
Overview of Singapore medical device regulations. In Singapore, medium- and high-risk medical and in vitro diagnostic (IVD) devices must be registered with the Health Sciences Authority (HSA).
