On June 7, Li Li, Secretary of the Leading Party Members Group and Commissioner of National Medical Products Administration (NMPA), presided over a meeting, at which the arrangement for tougher regulation over medical device clinical trial facilities were studied and the Measures for Supervision and Inspection of Medical Device Clinical Trial Facilities (Trial) were deliberated and adopted.
It was noted that clinical trial is an important process and guarantee to prove the safety and effectiveness of medical device products before marketing and that clinical trial facilities play a vital role in guaranteeing the quality of clinical trials and safeguarding the rights and interests of subjects. With the focus on the responsibilities of regulatory authorities at all levels, the institutionalization requirements of inspection, the work processes of supervision and inspection, the handling methods for different inspection results and the collaboration requirements, the Measures for Supervision and Inspection of Medical Device Clinical Trial Facilities (Trial) is not only conducive to guiding drug inspection institutions at all levels to strengthen the management of medical device clinical trial facilities and conduct the supervision, inspection and risk treatment in a standardized manner, but also beneficial to urging clinical trial facilities to safeguard the rights and interests and protect the safety of subjects practically, ensure the standardized implementation of trials and make sure that the clinical trial results are true, accurate, complete and traceable.
The Measures for Supervision and Inspection of Medical Device Clinical Trial Facilities (Trial) will come into effect from October 1, 2024. NMPA will subsequently issue the Key Points and Determination Principles for Supervision and Inspection of Medical Device Clinical Trial Facilities and organize publicity and training activities to improve the inspection capability and level of drug regulatory authorities.
Source: National Medical Products Administration (NMPA)
It was noted that clinical trial is an important process and guarantee to prove the safety and effectiveness of medical device products before marketing and that clinical trial facilities play a vital role in guaranteeing the quality of clinical trials and safeguarding the rights and interests of subjects. With the focus on the responsibilities of regulatory authorities at all levels, the institutionalization requirements of inspection, the work processes of supervision and inspection, the handling methods for different inspection results and the collaboration requirements, the Measures for Supervision and Inspection of Medical Device Clinical Trial Facilities (Trial) is not only conducive to guiding drug inspection institutions at all levels to strengthen the management of medical device clinical trial facilities and conduct the supervision, inspection and risk treatment in a standardized manner, but also beneficial to urging clinical trial facilities to safeguard the rights and interests and protect the safety of subjects practically, ensure the standardized implementation of trials and make sure that the clinical trial results are true, accurate, complete and traceable.
The Measures for Supervision and Inspection of Medical Device Clinical Trial Facilities (Trial) will come into effect from October 1, 2024. NMPA will subsequently issue the Key Points and Determination Principles for Supervision and Inspection of Medical Device Clinical Trial Facilities and organize publicity and training activities to improve the inspection capability and level of drug regulatory authorities.
Source: National Medical Products Administration (NMPA)