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FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products.
Visit linkhttps://www.fda.gov/medical-devices
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations. Find out more
Medical devicesFind out more
Resources related to and required for sale of medical devices in Canada including legislation, Health Canada guidelines, applications and submissions, fees, licences and quality system requirementsFind out more
The International Medical Device Regulators Forum (IMDRF) aims to accelerate international medical device regulatory harmonization and convergence.Find out more
