July 13, 2018

CNDA welcomes public comments on the recently drafted policy entitled, "Principles of the Clinical Trial Inspection for Medical Devices", hereby referred to as "Principle".

The Pinciple aims to strengthen the supervision and management of the clinical trial process of medical devices, and shall include the following sections: "Clinical Trial Preparation", "Protection of Subjects' Rights", "Clinical Trial Program", "Clinical Trial Process", "Recording and Reporting", "Management of Medical Devices / In vitro Diagnostic Reagents for Clinical Trial", and "Management of Clinical Test Samples (applicable to IVD)".

Reference: Official press