The medical devices approvals / certification are treated differently in different countries and controlled by the local authorities. For example in European Union, requirements related to medical devices are illustrated in the form of directives. Medical devices, active implantable medical devices and in vitro diagnostic medical devices can be placed in European market only after, once they are CE marked. CE mark, can be achieved by showing compliance to the applicable directives of European Union. Similarly in USA, it is necessary to obtain the FDA clearance before placing medical devices into the market. In Canada, it is necessary to register certain medical devices with Health Canada before placing the devices in the market.
It is important that the manufacturer identifies the right category of the product such as medical devices, in vitro diagnostic medical devices or medicinal (drug), before looking for regulatory requirements. Many cases the difference between these categories are very small, however there are huge difference in the requirements. For Example medicinal (drug) products cannot be CE marked. If it is electro medical devices the product needs to show compliance to IEC/EN 60601-1 series of standards where there are very strict requirements for leakage current. If the device is an active in vitro diagnostic device (IVD) then the product needs to show compliance according to safety standard IEC/EN 61010-1 where the limits for leakage current are far relaxed than a medical devices.
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