Singapore 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 | 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 …

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

Class A medical devices. GN-22 R7.4 Guidance for Dealers on Class A Medical Devices (22 Mar-pub) 336 KB; Good Distribution Practice for Medical Devices …

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 …

Medical Device Registration and Approval in …

https://www.emergobyul.com/services/medical-device-registration-and-approval-singapore

Device classification in Singapore is based on a four-tier system (Class A, B, C, and D), with Class A assigned to the lowest-risk products and Class D assigned to the highest-risk products. Devices with prior …

Medical Device Classification in Singapore (HSA …

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

From the Singapore HSA website, the definition a medical device is: “Medical device” means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or …

Singapore Regulatory Approval Process for Medical …

https://www.emergobyul.com/resources/singapore-regulatory-approval-process-medical-devices

The medical device approval process in Singapore explained Step 1 Medical Devices in Singapore are governed by the Health Sciences Authority (HSA). Determine the classification of your medical device …

Listing of Registered Medical Devices - Data.gov.sg

https://data.gov.sg/dataset/listing-of-registered-medical-devices

Listing of Registered Medical Devices-Data.gov.sg Listing of Registered Medical Devices FILES IN THIS DATASET Listing of Registered Medical Devices - Dec 2021 …

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