Medical Device Regulatory Agencies

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Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

Medical Device Listing - 21CFR Part 807 Manufacturers must list their devices with the FDA. Establishments required to list their devices include: manufacturers, contract manufacturers,...

International Medical Device Regulators Forum (IMDRF)

https://www.imdrf.org/

We strategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is …

International Medical Device Regulators Forum (IMDRF) …

https://www.fda.gov/medical-devices/cdrh-international-programs/international-medical-device-regulators-forum-imdrf

The current IMDRF members represent medical device regulatory authorities in: Australia - Therapeutic Goods Administration Brazil - National Health Surveillance Agency …

Medical Device Regulations & Compliance - Med Device …

https://www.meddeviceonline.com/resource/medical-device-regulations

The International Medical Device Regulators Forum (IMDRF) — composed of regulatory agencies from Australia, Brazil, Canada, China, Europe, Japan, Russia, and the United …

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 …

Medical Device Regulatory Authorities - Regulatory Convergence

https://www.interamericancoalition-medtech.org/regulatory-convergence/quick-links/medical-device-regulatory-authorities/

The U.S. Food and Drug Administration (FDA) is the United States agency that regulates medical devices The U.S. Food and Drug Administration (USFDA) Center for Devices …

Global Regulatory Authority Websites - PDA

https://www.pda.org/scientific-and-regulatory-affairs/regulatory-resources/global-regulatory-authority-websites

Japan: Pharmaceuticals and Medical Devices Evaluation Agency Japan: Ministry of Agriculture, ...

The Essential List of Regulatory Authorities …

https://www.raps.org/news-and-articles/news-articles/2020/1/the-essential-list-of-regulatory-authorities-in-eu

Jan 22, 2020

List of national authorities for Medical Devices

https://easymedicaldevice.com/list-national-authorities-medical-devices/

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Overview of New Brazilian Regulation RDC 751/2022

https://www.emergobyul.com/resources/overview-new-brazilian-regulation-rdc-7512022

Webinar date Feb. 14, 2023 Speakers Luiz Levy, RAC, manager, Quality and Regulatory Affairs Brazil Sarah Mundim, senior Quality and Regulatory Affairs …

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