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Medical devices - World Health Organization
- https://www.who.int/health-topics/medical-devices
- Member States recognized in World Health Assembly (WHA) resolutions WHA60.29 (2007) and WHA 67.20 (2014) that medical devices are indispensable for …
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 …
Digital Health Policy Navigator | FDA
- https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-policy-navigator
- If you are developing a digital health or software product, it may contain software functions that are considered devices as that term is defined in section 201 (h) …
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 …
Health products policy and standards - World Health …
- https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/policies
- It addresses the role of medical devices in global health care and the prioritization of needs within Member States and discusses the key components of an …
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
- Introduction Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas …
Global atlas of medical devices - World …
- https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/global-atlas-of-medical-devices
- The Global Atlas of medical devices (GAMD) provides global, regional and country data on availability of: national policy on health technology regulation of medical devices health technology …
Digital Health Policies and Public Health Solutions for …
- https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/digital-health-policies-and-public-health-solutions-covid-19
- Policy for Device Software Functions and Mobile Medical Applications (MMA); Enforcement Policy for Digital Health Devices For Treating Psychiatric …
Medical Devices - Sector - Public Health
- https://health.ec.europa.eu/medical-devices-sector_en
- The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively... New Regulations …
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 …
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