Asia
Philippines Food and Drug Administration (FDA), the national authority responsible for medical devices market regulation, has announced the implementation of a new regulatory framework for medical devices. New Medical Device Regulation: General Principles and...
Asia
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...
Europe
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...
Uncategorized
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...
Asia
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...
#WednesdayWebinar Join us for our upcoming webinar Global Regulatory Changes to Expect in 2025 January 22, 2025 at 10 AM ET
Register Now
