Study Design, Evaluation and Inspection of Good Clinical Practice in Medical Device

Following the proclamation of ISO 14155-1:2003 “Clinical investigation of medical devices for human subjects -- Part 1: General requirements” that integrates the standards of clinical practices in medical devices in the U.S. and European Union (EU) and referring to the protocol of Good Clinical Practices in clinical trials and international standards ISO 14155-1, the draft of Good Clinical Practices in Medical Device has been in preparation alongside with the suggestions from some related organizations in the aim at elevating the standards of clinical practices in medical devices. This study focuses on setting up a model of evaluations and inspections of medical devices in GCP manners in order to provide some foundational suggestions to those authorities concerned so as to facilitate the law enactment. This study is a two-year research project. The purpose of the study at the 1st year is to carefully evaluate the availability of all kinds of inspection items and to get a good understanding of the current trend of clinical practices in medical devices and its actual executions in Taiwan. After getting such knowledge, some adjustments will be propose in order to make its function complete. In the aspects of its practical operations and personnel responsibilities, the good clinical practices in medical devices inherit the essence of its counterpart in clinical trials. In the aspects of technology, however, it differs from those in clinical trials. Some proper adjustments, such as the records of medicine disposal and management in clinical GCP should be made to the confirmation of the number of used medical devices (disposable devices vs. permanent devices). Due to the very nature of the special structure and usage of medical devices, the appropriateness of blindness design should be taken into further account.

Project ID:PG9603-0169
External Project ID:DOH96-TD-D-113-001-(2/2)