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Colombia INVIMA Medical Device Regulatory Approval Process
To market a medical device or IVD, manufacturers must register with the National Food and Drug Surveillance Institute (INVIMA), the country’s medical
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Costa Rica medical device & IVD approval process
Medical device manufacturers who want to enter the Costa Rican market need to obtain approval from the Costa Rican Ministry of Health. There are a
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Europe CE Marking Regulatory Process for Medical Devices
In order to commercialize medical devices in the European Union , a CE Mark certificate is needed. This certification verifies that a device meets
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European IVD Regulatory Approval Process
IVD devices (In Vitro Diagnostics) are a subset of medical devices primarily used for to testing human fluids such as blood, tissue or urine in a
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Europe Medical Devices Regulation (MDR) CE Marking Regulatory Process
In order to commercialize medical devices in the European Union , a CE Mark certificate is needed. This certification verifies that a device meets
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Europe In Vitro Diagnostic Devices Regulation (IVDR) CE Marking Regulatory Process
In order to commercialize in vitro diagnostic (IVD) devices in the European Union , a CE Mark certificate is needed. This certification verifies that
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Hong Kong Approval Process for Medical Devices
Medical devices in Hong Kong are regulated by the Medical Device Control Office (MDCO).Though the decision to register devices in Hong Kong is
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