Category: Medical Device

European Medicines Agency (EMA) has implemented a new system to issue electronic certificates for human and veterinary medicines. As of today, the Agency will no longer provide printed certificates...

Globalization of the market has greatly enhanced competition and pressure on manufacturers to develop new and high-quality products faster at a low cost. To stay competitive, manufacturers should be...

European Medicines Agency (EMA) explained considerations for implementing the International Council of Harmonisation’s (ICH) Q12 guideline on technical and regulatory considerations for pharmaceutical...

The Danish Medicines Agency recommended newly enhanced reporting requirements on medical devices to ensure that the surveillance of medical devices becomes more focused for the benefit of patients. This...

The US Food and Drug Administration (FDA) announced to ban electrical stimulation devices (ESDs) used to treat aggressive behaviour or self-injurious, denoting the third time in the agency’s history...

Prior preparation is necessary for an immediate investigation of incidents once they occur. This is necessary not only because you are keen on ensuring patient safety but also as immediate action has...