Singapore Medical Device Classification Rules

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HSA | Risk classification of medical devices

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

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 channeling or storing body liquids or gases Rule 2 (ii): Non-invasive devices for channeling blood or blood components, or … See more

HSA | Guidance documents for medical devices

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

Medical devices Guidance documents for medical devices Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory …

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 Device Product Classification Guidance for Singapore

https://andamanmed.com/medical-device-product-classification-guidance-singapore/

Medical Device Product Classification Guidance for Singapore Medical Device Product Classification Guidance for Singapore December 10, 2021 Regulatory …

Singapore UDI regulations for medical …

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

Singapore HSA Finalizes Unique Device Identification (UDI) Requirements for Medical Devices August 30, 2021 Singapore’s medical device market …

Medical Device Classification in Singapore (HSA …

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

In this instance, it would rightfully be classified under Rule 10 (i) as a Class B device, where it is intended to diagnose/monitor the physiological condition of the heart. It is not a Rule …

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 …

A Complete Guide to Licensing Medical Devices in …

https://sleek.com/sg/resources/medical-devices-licensing/

Medical devices in Singapore are classified into 4 risk classes – Class A, B, C and D; Class A being the lowest risk and Class D the highest risk. Factors affecting medical …

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