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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, …

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 …

Health Products (Medical Devices) Regulations 2010

    https://sso.agc.gov.sg/SL/HPA2007-S436-2010
    the components or composition of the medical device; (d) the fitness for purpose (including expiry date), strength, performance, behaviour or accuracy of the …

Health Products (Medical Devices) (Amendment No. 2) …

    https://sso.agc.gov.sg/SL-Supp/S950-2022/Published/20221209?DocDate=20221209
    These Regulations are the Health Products (Medical Devices) (Amendment No. 2) Regulations 2022 and come into operation on 9 January 2023. Amendment of …

QUICK GUIDE TO MEDICAL DEVICE PRODUCT …

    https://www.hsa.gov.sg/docs/default-source/hprg-mdb/quick-guide-to-md-registration-and-licensing_may-2021.pdf
    devices in Singapore • Import of medical devices into Singapore • Wholesale of medical devices in Singapore (including export) 1 The scope of ISO 13485 certificate shall …

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...

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 in …

    https://www.emergobyul.com/services/medical-device-registration-and-approval-singapore
    These regulations dictate how medical devices are classified in Singapore and the registration routes for each class. Device classification in Singapore is based on a four-tier system (Class A, …

Medical Device Regulation: Importance and …

    https://apacmed.org/medical-device-regulation/
    In Singapore, all medical devices are regulated by the Health Sciences Authority (HSA). Scope A dealer’s license is required for companies that seek to manufacture, import or sell medical …



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