Medical Divices

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

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

Comprehensive List of Latest CDRH Updates Products and Medical Procedures Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity,...

Medical devices - World Health Organization

https://www.who.int/health-topics/medical-devices

Today, there are an estimated 2 million different kinds of medical devices on the world market, categorized into more than 7000 generic devices groups. A medical …

How to Determine if Your Product is a Medical Device | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

What are Medical Devices? - News-Medical.net

https://www.news-medical.net/health/What-are-Medical-Devices.aspx

A medical device is considered any apparatus that does not exert its action through chemical means and is used in diagnosis, mitigation, therapy, or prevention of …

Medical Device Safety | FDA

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

Medical Device Safety | FDA Medical Device Safety The FDA monitors reports …

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 …

Importing Medical Devices | FDA

https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices

What is a medical device? The FDA defines a medical device as: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or …

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 …

Medical Device Classification (FDA & EU MDR)

https://www.simplerqms.com/medical-device-classification/

Class II medical devices are defined by the FDA as follows: “devices for which general controls are insufficient to provide reasonable assurance of the safety and …

What is a Medical Device? (Official definition for EU, …

https://easymedicaldevice.com/medical-device-definition/

‘medical device’means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings …