제출자료가 누락됐는지 미리 확인하는 절차가 생겼으며 국제표준화기술문서 작성 의무대상인 4등급 의료기기 허가 신청시 제조공정만 작성하도록 했다.
There is now a procedure to check in advance whether anything has been omitted from the submitted data, and only the manufacturing process was to be completed when applying for permission for Grade 4 medical devices, which are mandatory to prepare international standardized technical documents.