Singapore Hsa Medical Device Guidance

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HSA | Guidance documents for medical devices

https://www.hsa.gov.sg/medical-devices/guidance-documents

GN-10-R3.6 Guidance on Medical Device Field Safety Corrective Action (Updated on January 2020) 666 KB. GN-10 Annex 1 Declaration on Completion of Correction Template (Updated on August 2018) 97 KB; Recall of medical devices . GN …

HSA | Medical devices

https://www.hsa.gov.sg/medical-devices

Medical devices are health products which have a physical or mechanical effect when used on human bodies. These devices are used to: Diagnose, alleviate or treat a medical …

MEDICAL DEVICE GUIDANCE - Health Sciences …

https://www.hsa.gov.sg/docs/default-source/medical-devices/gn-13-r2-1-guidance-on-the-risk-classification-of-general-medical-devices-(18sep-pub).pdf

medical device guidance september 2018 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 10 of 36 NON-VIABLE (as set out in the …

HSA | Registration guides

https://www.hsa.gov.sg/medical-devices/registration/guides

Registration guides. Once you have determined the evaluation route and risk class of your medical device, use the relevant guide to find out the documents, fees and processing …

HSA | Digital Health

https://www.hsa.gov.sg/medical-devices/digital-health

Under this scheme, we provide consultation to researchers, developers and manufacturers of digital health devices, software, apps and AI solutions. To date, digital health products constitute over 40% of these consultations. …

HSA | Bringing personal medical devices into Singapore

https://www.hsa.gov.sg/medical-devices/personal-import

You are not allowed to bring in the following medical devices through personal import: HIV test kits. Medical devices with radiation such as X-Rays, lasers, ultrasound, which are …

Singapore UDI regulations for medical devices and …

https://www.emergobyul.com/news/singapore-hsa-finalizes-unique-device-identification-udi-requirements-medical-devices

August 30, 2021. Singapore’s medical device market regulator, the Health Sciences Authority (HSA), has published final guidance for Unique Device Identification (UDI) regulations covering …

HSA | Notify changes to registered medical devices

https://www.hsa.gov.sg/medical-devices/change-notification

Technical changes to Class C and D medical devices. Review changes for Class B medical devices. Administrative changes that affect the Singapore Medical …

HSA Guidance on Medical Device Field Safety Corrective Action: …

https://www.regdesk.co/hsa-guidance-on-medical-device-field-safety-corrective-action-overview/

The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to Field …

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