Malaysia
The article describes updated guidance on re-registration and highlights the key aspects to be taken into consideration for the procedure. The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of medical devices, has published a second...
Malaysia
The article describes in detail the approach to be applied when determining the regulatory nature of borderline products as set forth by the current legislation in Malaysia. The Medical Device Authority (MDA), a body of the Ministry of Health Malaysia responsible for...
Malaysia
The Medical Device Authority (MDA), the Malaysian authority responsible for medical device regulations, has published updated guidance on advertising rules for medical devices intended to be marketed on the domestic market. The document is intended to assist medical...
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...
