South Korea’s Ministry of Food and Drug Safety (MFDS) has issued two guidance dedicated to certain aspects of medical device regulation. One pertains to imported medical devices and the other to scarce and unique devices. These documents had been previously...
One of the most significant steps made in 2019 in Montenegro surrounding the medical device regulatory framework was the adoption of the Law on Medical Devices. This established general principles related to manufacturing, distributing and supervising medical devices...
To assist medical device manufacturers in maintaining compliance with applicable requirements, the National Health Regulatory Authority (NHRA), the Kingdom of Bahrain’s agency responsible for medical device regulation, has published registration guidelines. Bahrain...
Bangladesh has recently published updated requirements for the manufacturing, importation, distribution and sales of medical devices on their domestic market. The Scope of the Guidelines At the moment, medical device circulation guidelines are regulated under the...
The National Administration of Drugs, Foods and Medical Devices (ANMAT), Argentina’s regulating authority in the sphere of medical device circulation, has recently issued the updated rules regarding the registration of medical devices. The most important amendments...