Europe
In Austria, the institution that oversees the regulation of medical devices is the Austrian Federal Office for Safety in Health Care (BASG). Medical devices in Austria are classified into the following three categories: Active implantable medical devices General...
EU MDR/IVDR
The European Union has established the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) as replacements to the Medical Devices Directive (MDD) and ln Vitro Diagnostic Devices Directive (IVDD), which had previously been in place for almost 25...
Europe
Over the last two decades, biologics have revolutionized the treatment of illnesses such as diabetes, cancer, rheumatoid arthritis and hepatitis. However, many prominent biologics are about to have their patents expire in the U.S., making way for biosimilars....
Europe
This chart lists the pharmaceutical, medical and related regulatory authorities of Commonwealth of Independent States (CIS) countries along with links to their relevant websites.
Africa
This chart lists the pharmaceutical, medical and related regulatory authorities of MENA regulations countries along with links to their relevant websites.
Europe
Last Friday, after a three year gridlock, the Council of the European Union came to an agreement on the reworking of regulatory legislation on medical devices and in vitro diagnostics which will impact both manufacturers and regulatory authorities. The European...
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