In order to strengthen the management of clinical trials of medical apparatus, safeguard the rights and interests of subjects in the process of clinical trials of medical apparatus, and ensure that the clinical trial process of medical apparatus is standardized, and the results are true, scientific, reliable and traceable, according to the "Regulations on the Supervision and Administration of Medical Apparatus", the Food and Drug Administration in conjunction with the National Health and Family Planning Commission has formulated and promulgated the "Quality Management Specifications for Clinical Trials of Medical Apparatus" (hereinafter referred to as the "Specifications"), which will come into force on June 1, 2016.

The "standard" for the first time by the provincial drug regulatory departments responsible for the supervision and management of clinical trials of medical apparatus, for serious or repeated clinical trial program deviation, suspected fraud and other situations to carry out verification. Industry insiders pointed out that the "standard" issued, indicating that after the drug clinical trial data verification storm, the medical apparatus field will also usher in the clinical data verification storm this year.