Asia
The Medical Device Authority (MDA), the department of the Ministry of Health Malaysia responsible for medical device regulations, has published guidance dedicated to the registration of conformity assessment bodies (CABs). The document consists of two parts: general...
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...
