Medical Devices Agency Guidelines

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Overview of Device Regulation | FDA

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

Manufacturers must list their devices with the FDA. Establishments required to list their devices include: manufacturers, contract manufacturers, contract sterilizers, repackagers and...

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in …

Medical Device Safety | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/medical-device-safety

Medical Device Safety The FDA monitors reports of adverse events and other …

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 …

Sterilization for Medical Devices | FDA

https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices

The FDA is working actively with sterilization experts, medical device manufacturers, and other government agencies to advance alternative ways to sterilize …

Devices Guidances | FDA - U.S. Food and Drug …

https://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/devices-guidances

Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff CDRH/CBER, June 2021 Enforcement Policy Regarding …

Pharmaceuticals and Medical Devices Agency - Pmda

https://www.pmda.go.jp/english/

February 14, 2023 MHLW Pharmaceuticals and Medical Devices Safety Information No.398 February 14, 2023 Revisions of PRECAUTIONS:Exenatide, etc. posted February 9, …

Managing medical devices - GOV.UK

https://www.gov.uk/government/publications/managing-medical-devices

This document outlines a systematic approach to the acquisition, deployment, maintenance (preventive maintenance and performance assurance), repair …

National Medical Products Administration - NMPA

http://english.nmpa.gov.cn/

Announcement of the Center for Food and Drug Inspection of NMPA on Issuing 5 Documents including the Work Procedures for Drug Registration Inspection (Trial) (No. …

Japan - Medical Devices - International Trade …

https://www.trade.gov/country-commercial-guides/japan-medical-devices

In April 2021, the MHLW established an office dedicated to SaMD development, as did the Pharmaceutical and Medical Device Agency (“PMDA”), a GOJ …

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