Medical Devices
Technical Dossier Evaluation

Technical Dossier Evaluation

Technical Dossier Evaluation

As commissioned by Taiwan Food & Drug Administration (TFDA), CDE conducts technical dossier evaluation on medium to high risk product submissions, as well as reviews on clinical trial protocols. At present, CDE assists government agencies in providing regulatory evaluations on medical device cases. And helps provide National Biotech Program with regulatory analyses on medical device cases. These efforts serve to ensure safety and effectiveness of pharmaceutical products on the market through sufficient pre-market technical dossier evaluations.

Ⅰ. Medical device registration
  1. According to Article 40 of the Pharmaceutical Affairs Act, CDE conducts premarket evaluation on technical dossiers for medium to high risk medical device products. These efforts serve to ensure safety and effectiveness of the products.
Ⅱ. Clinical investigation
  1. According to Article 44 of the Pharmaceutical Affairs Act, CDE assesses clinical trials, human trials and trial protocols, as well as inform contents and relevant issues. The purpose of these efforts is to protect the safety of human subjects.
Ⅲ. Regulatory evaluations and recommendations
  1. CDE provides regulatory analysis and/or regulatory strategic recommendations to the government on important biomedical programs or projects financed by the government. Furthermore, CDE assists TFDA in the formulation of medical devices regulations and guidelines as well as the assessment and collection of domestic and international regulatory information on medical devices in order to facilitate and promote cooperation and harmonization of international regulatory affairs.