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Medical Device Regulation in 2023: A Window of Opportunity

    https://alirahealth.com/education-hub/medical-device-regulation-in-2023/
    The Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (so called Medical Device Regulation -MDR-) became fully applicable beginning in May 2021. The transition period, during which manufacturers …

Health products policy and standards - World Health …

    https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/regulations
    The 67th WHA approved the resolution “Regulatory system strengthening for medical products." It states the importance of regulations for medical devices as one of the …

January 10, 2023 updates to list of medical devices for …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/2023-01-09-changes-reporting-medical-device-shortage.html
    Health Canada has updated the List of Medical Devices – Notification of Shortages on January 10, 2023, to add medical devices that require mandatory …

Health Products (Medical Devices) Regulations 2010

    https://sso.agc.gov.sg/SL/HPA2007-S436-2010
    Health Products Act. (Chapter 122D) Health Products (Medical Devices) Regulations 2010. In exercise of the powers conferred by sections 45, 71 and 72 of the Health …

Medical devices - World Health Organization

    https://www.who.int/health-topics/medical-devices
    Policies, strategies, and action plans for health technologies, specifically for medical devices, are required in any national health plan. Within the context of a robust …

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

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

Federal Register :: Radiological Health Regulations; …

    https://www.federalregister.gov/documents/2023/01/20/2023-00922/radiological-health-regulations-amendments-to-records-and-reports-for-radiation-emitting-electronic
    Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for …

UK MHRA Updates Roadmap for New Medical Device Regulations

    https://www.emergobyul.com/news/uk-mhra-updates-roadmap-new-medical-device-regulations
    January 24, 2023. By Karen Hill and Evangeline Loh. The MHRA presented a webinar on the UK Medical Devices Regulations on January 24, 2023. …

Forward Regulatory Plan 2022-2024: Regulations …

    https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/forward-regulatory-plan/plan/modernization-regulation-clinical-trials.html
    Forward Regulatory Plan 2022-2024: Regulations Amending the Food and Drug Regulations, Natural Health Products Regulations and the Medical Devices …

Medical devices | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
    The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …



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