The new policy set by TFDA-Medical device management act
Due to the diversified development and types of medical device in recent years, it is gradually different from the drug management model. And the risk level of medical device is determined according to the classification and grading management.
Summary of acronym list in clinical trial
A clinical trial is trial conducted with patients, evaluating new treatments, drugs or devices, in patients. They can also test improved procedures of treating, preventing, screening and diagnosing disease in patients.
Obligation on icons and symbols to display for manufacturers of medical devices
EN ISO 15223-1:2021 has been updated and replace ISO 15223-1:2016 with the aim to improve definitions and descriptions through new symbols for comply with various regulatory requirements.
