In February 2016, the Malaysia Medical Device Authority (MDA) released a set of guidelines that will help medical device manufacturers comply with Malaysia’s regulations. The guidelines will support manufacturers as they complete the Declaration of Conformity, a legal document drawn up by manufacturers assuring that the device complies with all applicable laws. The guidelines provide detailed definitions of key words found in the Declaration of Conformity. The guidelines also emphasize that the Declaration of Conformity must be signed by top management.
