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Mexico COFEPRIS Regulatory Approval Process for Medical Devices and IVDs
In Mexico, medical devices and In-Vitro Diagnostic (IVD) devices are governed by COFEPRIS, a division within the Mexican Ministry of Health (
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Russia Approval Process for Medical Devices
To obtain access to the Russian Federation, medical device manufacturers will have to undergo a challenging registration process. Unlike other
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Saudi Arabia Regulatory Approval Process for Medical Devices
The chart shown illustrates the Saudi Arabia approval process and is available for download in PDF format. However, if you would like to explain the
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Singapore Regulatory Approval Process for Medical Devices
In Singapore, medical devices are overseen by the Health Sciences Authority (HSA). Classification of devices is similar to the system in Europe, but
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South Korea MFDS Regulatory Approval Process for Medical Devices
Medical device and IVD manufacturers that want to sell their products in South Korea will have to follow the requirements of the Medical Devices Act
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Taiwan TFDA Regulatory Approval Process for Medical Devices & IVDs
All manufacturers planning to sell a medical device in the Taiwan need to register their product with the Taiwan Food and Drug Administration (TFDA
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US FDA Registration Process for Medical Devices and IVDs
All companies planning to sell a medical device or IVD in the United States need to register their product with the US FDA. Most Class I devices can
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