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

Due to the hazard facts that medical materials and/or medical devices that being used directly or indirectly in the human beings through the means of clinical investigation, diagnose, treatment, physical therapies and experiments, all the usages of such materials and devices before approval are required to conduct clinical trials. These will be derived through the scientific hypothesis using the clinical data from the trials which will be used as the evidence in proving the efficacy and safety issues. There are international standard available in US and EMEA in Europe such as ？§ISO 14155: clinical trial standard for medical devices？？. The Good Clinical Practice of Medical devices are under construction in Taiwan using the same concept from ISO 14155. The primary aim for this research projects is to establish the evaluation procedures of medical devices and set up the GCP inspection evaluation procedures. The conducts of the medical devices clinical trials should be the same as those clinical trials in new drug and new medication. However, the procedures in the technique and practical consideration due to the nature of the trials should be considered in details. This research project is a two year term project. In the first year, we will survey all the medical devices clinical trials classification and understand the trends to propose the appropriate inspection items for medical devices. We will do the simulation GCP inspection for medical devices clinical trials under the guidance from the DOH in the second year. There will be an workshop planned for all the medical devices industry to participate and to exchange the know how and opinions to the government.

Project ID:PG9502-0540
External Project ID:DOH95-TD-D-113-003-(1/2)