Medical Devices Classification Singapore

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HSA | Risk classification of medical devices

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

A number of factors affect medical device risk classification. These include: 1. The duration of medical device contact with the body. 2. The degree of invasiveness. 3. Whether the medical device delivers medicinal products or energy to the patient. 4. Whether they are intended to have a biological effect on the patient. 5. … See more

HSA | Guidance documents for medical devices

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

Medical Devices Product Classification. Medical Devices Product Classification Guide 2148 KB; Product Specific Regulatory guidelines. Telehealth …

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 …

HSA | Regulatory overview of medical devices

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

All medical devices will require registration with us before they can be supplied in Singapore, except for Class A low risk medical devices, which are exempted from …

Medical Devices Product Classification Guide

https://www.hsa.gov.sg/docs/default-source/hprg-mdb/regulatory-updates/medical-devices-product-classification-guide.pdf

Medical Devices Product Classification Guide

Medical Device Classification in Singapore - Emergo

https://www.emergobyul.com/services/classification-medical-devices-singapore

The first step in the Singapore registration process is to determine the classification of your device by referencing the Health Sciences Authority's GN-13: Guidance on the Risk …

How medical devices are regulated by HSA

https://www.hsa.gov.sg/consumer-safety/articles/how-medical-devices-are-regulated-by-hsa

Medical devices have a physical or mechanical effect on the body, and are used to diagnose, alleviate or treat medical conditions. They may also be used to measure or …

Medical Device Classification in Singapore (HSA …

https://stendard.com/en-sg/blog/medical-devices-classification/

Medical Device Classification Once you have determined the “Intended Use” and it falls within the medical device definition, the next step would be to understand which risk …

Classify Your Medical Device | FDA

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

The three classes and the requirements which apply to them are: Device Class and Regulatory Controls 1. Class I General Controls With Exemptions Without Exemptions 2. …

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HSA | Risk classification of medical devices

HSA | Guidance documents for medical devices

HSA | Medical devices

HSA | Regulatory overview of medical devices

Medical Devices Product Classification Guide

Medical Device Classification in Singapore - Emergo

How medical devices are regulated by HSA

Medical Device Classification in Singapore (HSA …

Classify Your Medical Device | FDA

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