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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 can be supplied in Singapore, except for Class A low risk medical devices, which are …

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 | Medical device registration and licensing …

    https://www.hsa.gov.sg/medical-devices/registration/requirements
    You are encouraged to check if your product is considered a medical device in Singapore. You will need to determine your medical device’s risk classification. If your medical …

How medical devices are regulated by HSA

    https://www.hsa.gov.sg/consumer-safety/articles/how-medical-devices-are-regulated-by-hsa
    How are medical devices regulated in Singapore? Product Registration - Medical devices must be registered with HSA to ensure they meet the regulatory requirements... Dealers’ …

A Complete Guide to Licensing Medical Devices in …

    https://sleek.com/sg/resources/medical-devices-licensing/
    The medical services industry in Singapore is regulated by The Health Sciences Authority (HSA) that administers the national regulatory framework for pharmaceuticals, …

Medical Device Registration and Approval …

    https://www.emergobyul.com/services/medical-device-registration-and-approval-singapore
    Foreign medical device manufacturers must appoint a Registrant to submit their device application and represent them to the HSA. The Registrant must be a Singapore …

HSA | Good Distribution Practice for Medical Devices

    https://www.hsa.gov.sg/medical-devices/dealers-licence/good-distribution-practice
    GDPMDS ensures that companies dealing with medical devices have quality management systems in place to maintain devices quality throughout the distribution …

HSA Guidance on Labeling for Medical Devices: …

    https://www.regdesk.co/hsa-guidance-on-labeling-for-medical-devices-introduction/
    General Labeling Requirements The authority outlines the main requirements to be followed concerning labeling for medical devices intended to be …



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