ABSTRACT
Application submission for the registration of medical products is usually made in the final stage following the time-consuming product development process. In that sense, it can be regarded as the compilation of all development program and activities on the product. In order to obtain early product approval, it is important for applicants to prepare and submit the application with a good- quality dossier. The principles of project management and quality management are critical for well-organized submission preparation. The submission practices of careful planning, good communications, and clearly defined work instructions can maximize the quality and efficiency of the submission process. Standard operating procedures may be structured to contain or refer to additional tools that could assist in performing the procedure for submission, for example, template, standard format of checklist. Each review authority has defined the acceptable format, process, and route of application submission, for example, hard copy or electronic dossier, online, mailing, or on-site submission.
