Medical Equipment Legislation

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Overview of Device Regulation | FDA

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

The quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing,...

Medical Equipment and Devices | Federal Trade …

https://www.ftc.gov/industry/health-care/medical-equipment-devices

Under the proposed order, Harmon and his companies must: stop making deceptive U.S.-origin labeling and advertising claims, provide substantiation for all …

Overview of Regulatory Requirements: Medical Devices

https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript

It basically says a medical device is “any instrument, machine, contrivance, implant, in vitro reagent that's intended to treat, cure, prevent, mitigate, diagnose disease in man”. Some …

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 …

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 …

New Medical ‘Right To Repair’ Legislation …

https://www.forbes.com/sites/sallypipes/2021/05/10/new-right-to-repair-legislation-endangers-california-patients/

The bill, along with similar versions that have been introduced this legislative session in a handful of states including Texas, Arkansas, and Hawaii, (the latter two …

Medical Device Repair Act: the Right to …

https://intermed1.com/medical-device-right-to-repair-act/

“The proposed legislation is designed to lift barriers that prevent healthcare providers from maintaining and repairing their medical equipment they desperately need to care …

RELEASE: Sanders, Khanna Unveil Emergency …

https://khanna.house.gov/media/press-releases/sanders-khanna-unveil-emergency-legislation-vastly-increase-medical-equipment

The Sanders-Khanna legislation provides an additional $75 billion for the Trump administration to purchase or manufacture personal protective equipment (such …

Equipment safety in health and social care services

https://www.hse.gov.uk/healthservices/equipment-safety.htm

Essentially, the Regulations require that lifting equipment is: strong and stable enough for the particular use and marked to indicate safe working loads; positioned and installed to …

The Medical Devices Regulations 2002 - Legislation.gov.uk

https://www.legislation.gov.uk/uksi/2002/618/contents/made

These Regulations contain the legislative measures necessary for the implementation of three European Community Directives: Council Directive 90/385/EEC on the …

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