European Union (EU) Essential Requirements Checklist and the Australian Principles Checklist for Medical Devices-Significance in a technical file and differences

Introduction The Australian Essential Principles Checklist (AEPC) is a list of 15 general and specific rules set by the Therapeutic and Good Administration (TGA). These, assist and simplify the assessment … Continue reading European Union (EU) Essential Requirements Checklist and the Australian Principles Checklist for Medical Devices-Significance in a technical file and differences