Singapore Hsa Medical Device Classification

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HSA | Risk classification of medical devices

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

The actual risk classification of each medical device must be considered individually, taking into account their design and intended purpose. Rules for general medical devices Rule 1: Non-invasive devices which come into contact with injured skin Rule 2 (i): Non-invasive devices for channeling tissues, or … See more

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 | 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 …

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, the operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and …

HSA | Regulatory overview of medical devices

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

We require companies to obtain a dealer's licence before manufacturing, importing or supplying medical devices. All medical devices will require registration with us before they …

HSA | Registration overview of medical devices

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

The following medical devices cannot take the expedited Class C (ECR) route. These devices can only be registered via the full or abridged routes. Hip, knee and shoulder joint …

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/

Scenario: A company would like to identify the risk classification of its new electrocardiogram (ECG) under Singapore HSA’s regulation. Intended use – The Alpha …

Medical Device Classification in Singapore - Emergo

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

The IVD classification system in Singapore has four classes and is also governed by risk. There are seven classification rules for IVDs. The system is as follows: Class A: Low …

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