Medical Device Regulation is based on rules about the development, validation, and maintenance of medical devices. The Medical Devices Regulations provide a mechanism to authorize the sale or importation of devices to be used for the purposes of clinical trials involving human subjects. The main aim for us is to guarantee the introduction and maintenance of effective technologies that can be safely adopted by the users. 

Medical Devices manufacturers and importers are required to have an authorization from DRAP in the form of Establishment Licenses.  We provide them with the authorization for their Licenses which help them to authorize the sale or importation of devices to be used for the purposes of clinical trials involving human subjects.