Hsa Class A Medical Device

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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 condition, e.g. X-ray machines, contact lenses, prosthetic knee implants. Measure or …

HSA | Medical Device Information Communication …

https://www.hsa.gov.sg/e-services/medics

HSA | Medical Device Information Communication System (MEDICS) Home E-services Medical Device Information Communication System (MEDICS) View medical device …

HSA | Certificates

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

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Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

Classify Your Medical Device | FDA Classify Your Medical Device The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different …

HSA | Risk classification of medical devices

https://www.hsa.gov.sg/medical-devices/registration/risk-classification-rule

HSA | Registration overview of medical devices

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

Class B, C and D registration. Registration requirements. Registration requirements. Refer to the table below for an overview of the evaluation routes for Class B, C and D medical …

Class I and Class II Device Exemptions | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions

A class I or class II device that is exempt from 510 (k) requirements must still comply with other requirements (known as regulatory controls) unless the device is …

HSA Guidance for Dealers on Class A Medical Devices: Overview

https://www.regdesk.co/hsa-guidance-for-dealers-on-class-a-medical-devices-overview/

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

Devices Approved in 2021 | FDA

https://www.fda.gov/medical-devices/pma-approvals/devices-approved-2021

Devices Approved in 2021. This page lists all medical devices approved through the CDRH Premarket Approval process (PMA) in 2021. For access to the …

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