Asia
The Pharmaceutical and Medical Devices Agency (PMDA), the Japanese medical device regulating authority, issued a Safety Information notice dedicated to the recent trends in cybersecurity assurance of medical devices. Regulatory Background According to the position of...
Asia
The Ministry of Health, Labour and Welfare of Japan (MHLW), the Japanese regulating authority responsible for medical device circulation, issued updated guidance dedicated to biocompatibility testing of medical devices. Biocompatibility Testing Standards According...
Asia
Japan announced the adoption of the new version of the Pharmaceuticals and Medical Devices (PMD) Act, the core document regulating the Japanese sphere of medicines and medical devices. New Japanese Medical Device Regulations: an Overview The novelties introduced in...
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...
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...
