Legislation Medical Devices

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Overview of Device Regulation | FDA

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

In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions....

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

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

International Medical Device Regulators Forum, Medical Device Single Audit Program (MDSAP) Resources for You Information for consumers and health care providers, letters …

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 Regulation Act - Wikipedia

https://en.wikipedia.org/wiki/Medical_Device_Regulation_Act

New Medical ‘Right To Repair’ Legislation …

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

Here in California, state lawmakers are currently considering legislation that would severely …

Health products policy and standards - World Health …

https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/regulations

Regulation is primarily concerned with enabling patient access to high quality, safe and effective medical devices, and avoiding access to products that are unsafe. When …

H.R.1090 - To amend the Federal Food, Drug, and …

https://www.congress.gov/bill/118th-congress/house-bill/1090/text

As of 02/18/2023 text has not been received for H.R.1090 - To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and …

Factsheet: medical devices overview

https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/factsheet-medical-devices-overview

A medical device is any apparatus, appliance, software, material or other article, whether used alone or in combination, intended by the manufacturer to be used by …

Legislative changes in the field of medical devices

https://www.havelpartners.cz/en/legislative-changes-in-the-field-of-medical-devices/

The new Act No. 375/2022 Sb. on Medical Devices and In Vitro Diagnostic Medical Devices (the “ Medical Devices Act ”) was adopted in furtherance of Regulation (EU) …

House Bill 36 | 135th General Assembly | Ohio Legislature

https://www.legislature.ohio.gov/legislation/135/hb36

Enrolled bills are the final version passed by the Ohio General Assembly and presented to the Governor for signature. The official version of acts signed by the Governor are …

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