MDAL and MDEL are the acronyms of Medical Device Application License and Medical Device Establishment License, respectively product license and establishment [...]
Medical Device marketing authorization in Brazil involves both registration with ANVISA and, in some cases, a product certification process. Particularly, in [...]
The 510(k), or Premarket Notification, is the FDA most frequently required process to medical device manufacturers to market their devices in [...]
In order to market Medical Devices in China, manufacturers shall appoint a Legal Agent established in China who plays an important [...]
