Mobile phones have become such an influential factor of our daily lives that it is almost a necessity for us. It provides efficient solutions to many tasks such as banking, shopping, and much more. With its such prevalent use, manufacturers are seeking ways to use...
European Commission informed that as a result of implementation of medical device and in vitro diagnostic regulations, there could be an issue of availability of several types of devices. The root of the problem is due to some manufactureres deciding to suspend the...
Health Canada recently stated that their regulatory fees of medical devices will increase significantly. Overall, the regulatory cost increased by 43%. Stakeholders of Health Canada stated that the fees should be increased in a more steady manner, rather than such...
Medical devices in Greece are regulated by The National Organization for Medicines (EOF), a public entity of the Ministry of Health. Greece, as a member of European Union, classifies medical devices according to their risk into four classes: I, IIb, IIb, and III....
The Australian regulatory authority, the TGA, is taking steps to improve the existing regulation in the sphere of manufacturing and use of medical devices through what is known as the “Action Plan”. The main goal of the Action Plan, published on April 4, 2019, is to...