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Department of Health | Medical Device Division

    https://www.mdd.gov.hk/en/home/index.html
    Measure of using HK registered drugs and medical devices used in HK public hospitals in Guangdong-Hong Kong-Macao Greater Bay Area; Listed Rapid Antigen Tests for COVID-19 under MDACS. ... obtained from the National Medical Products Administration and the Ministry of Food and Drug Safety of Korea under the Medical Device Administrative Control ...

Department of Health | Medical Device Division - Medical …

    https://www.mdd.gov.hk/en/about-us/medical-device-division/index.html
    The Medical Device Division (MDD), formerly known as Medical Device Control Office (MDCO), was established in July 2004. ... The purpose of regulation is to …

Department of Health - Medical Device Division

    https://www.dh.gov.hk/english/main/main_mdd/main_mdd.html
    The Medical Device Division (MDD), formerly known as the Medical Device Control Office (MDCO), was established in July 2004. The MDD is responsible for …

Department of Health | Medical Device Division

    https://www.mdd.gov.hk/en/mdacs/issued-documents/guidance-notes/index.html
    Guidance Notes (Note: The Medical Device Control Office has been renamed as the Medical Device Division with effect from 1 October 2019. Please refer to Contact Us …

Department of Health | Medical Device Division

    https://www.mdd.gov.hk/en/useful-information/frequently-asked-questions/index.html
    Currently, there is no specific legislation that regulates the manufacture, import, export and sale of medical devices in Hong Kong. However, depending on the nature and …

Hong Kong Medical Device and Pharmaceutical …

    https://www.pacificbridgemedical.com/regulation/hong-kong-medical-device-pharmaceutical-regulations/
    Hong Kong Medical Device Regulatory Webcast. The Hong Kong Medical Device Regulatory Update Webcast provides an in-depth coverage of Hong Kong’s regulatory system and regulations. …

Department of Health | Medical Device Division - Issued …

    https://www.mdd.gov.hk/en/useful-information/issued-documents-under-mdacs/index.html
    Issued Documents under Medical Device Administrative Control System (MDACS) (Note: The Medical Device Control Office has been renamed as the Medical Device Division …

Hong Kong Medical Device Registration - Asia Actual

    https://asiaactual.com/hong-kong/medical-device-registration/
    Medical Device registration in Hong Kong is managed by the Medical Device Division (MDD) of the Department of Health, formerly known as the Medical Device Control Office …

Hong Kong Approval Process for Medical Devices

    https://www.emergobyul.com/resources/hong-kong-approval-process-medical-devices
    Step 5. Your LRP submits the application to the MDCO. Step 6. MDCO reviews application and may request additional documentation or clarification. LRP must provide any responses to MDCO inquiries in a …

MDR Medical Device Regulation | BSI Hong Kong

    https://www.bsigroup.com/en-HK/Medical-Devices/medical-devices/MDR-Revision/
    Get in touch. Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, contact our expert team who will guide you …



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