Registration of manufacturers of medical devices that do not their have headquarters/temporary-permanent residence in Montenegro

The application for Registration of manufacturers of medical devices that do not their have headquarters/temporary-permanent residence in Montenegro, shall contain the following:

   1) contract or letter of authorisation issued by a foreign manufacturer to the applicant;

   2) documentation for responsible persons of the authorized representative for the registration procedure and vigilance of medical devices; and

   3) other data of importance for the registration of a manufacturer, in accordance with the Law.