Home » Malaysia Issues Final Guideline on Device Registration
Malaysia Issues Final Guideline on Device Registration
Malaysia’s Medical Device Authority has released a six-step guideline on registering devices through the regulator’s web-based system. Companies should determine whether the product is a medical device under the 2012 device law and then determine its appropriate classification and group. Next, they should conduct a conformity assessment and compile evidence of conformity with MDA regulations in a common submission technical document.
International Medical Device Regulatory Monitor
International Medical Device Regulatory Monitor
Upcoming Events
-
23Apr
-
25Apr
-
07May
-
14May
-
30May