Issuance of Measures for Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial Implementation)
ISSUING AUTHORITY:
National Medical Products Administration
DATE OF ISSUANCE:
June 14, 2024
EFFECTIVE DATE:
October 1, 2024.
On June 14, 2024, the National Medical Products Administration (NMPA) issued the Measures for Supervision and Inspection of Medical Device Clinical Trial Organizations (Trial Implementation) (the “Measures”), which took effect on October 1, 2024. The Measures are designed to enhance the management of medical device clinical trial institutions (“Trial Institutions”) and to standardize the supervisory inspection of Trial Institutions. Comprising six chapters, the Measures outline the responsibilities among drug regulatory departments at different levels, the qualifications required of trial inspectors, the protocols for conducting inspections, and the methods for managing the outcomes of these inspections.
Firstly, drug regulatory authorities are mandated to establish a quality management system for inspections. Inspectors must have the relevant qualifications and are expected to uphold disciplinary standards. This includes but is not limited to receiving integrity education prior to inspections, signing commitment letters, and declaring no conflict of interest.
Secondly, the Measures provide a comprehensive guide to the inspection process, which encompasses pre-inspection preparations, the establishment of inspection teams, notifications to the institutions under scrutiny, on-site inspection protocols, analysis and summarization of findings, final meetings, and the compilation of inspection reports, complete with specific requirements for each stage.
Last but not least, the Measures clarify the corrective actions that Trial Institutions need to take based on the problems identified during the inspection and the potential measures they might face, such as the suspension of new trials.
The Measures also emphasize the importance of safeguarding the rights and safety of trial subjects, and the necessity of ensuring that trial results are authentic, precise, comprehensive, and traceable, which is also an important reason for the supervision and inspection of Trial Institutions.
《国家药监局关于发布医疗器械临床试验机构监督检查办法（试行）的通告》
