Asia
The Food and Drug Administration (FDA) has published a safety communication dedicated to the use of the cold-therapy mode of water-circulating hot/cold therapy devices. The document is intended to remind the users of the aforementioned devices about the importance of...
Asia
The Medical Device Authority (MDA) of Malaysia has published a guidance document dedicated to the requirements for registration of conformity assessment bodies (CABs). In particular, the document describes the requirements the entity shall meet in order to be eligible...
Asia
The Medical Device Authority (MDA), a branch of the Ministry of Health Malaysia responsible for medical device regulation, issued guidance documents dedicated to handling complaints, and mandatory problem reporting. Regulatory Background The Malaysian regulating...
Asia
The Medical Device Authority (MDA), a special body of the Ministry of Health Malaysia responsible for medical device regulations, issued guidance on field corrective actions. Malaysian Medical Devices Regulatory Background The present MDA guidance is intended to...
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...
