A Summation Of The Safe Medical Devices Act
The SMDA Act is an act that sanctions the progressive reporting as well as tracking the regulations for the use of the medical devices. The medical devices defined under the Act involve the devices classified within the consent of the Medical Device Regulation Act. The Act is responsible for the mandate of reporting the requirements made by the manufacturers of medical devices.
The requirements hold with regards to the safety events as well as the product efficiency of the said devices. Based on the Act, the devices are classified with a substantial equivalence to the class II medical devices ( ...