Article 25 After the completion of the clinical trial of medical devices, the medical institution undertaking the clinical trial shall, in accordance with the requirements of the medical device clinical trial program and the prescribed format (Annex 3) issued a clinical trial report. Medical device clinical trial report should be signed and dated by the clinical trial personnel, and undertake clinical trials of medical institutions in the clinical trial management department to sign the opinion, date and seal.
Article 26 The report of clinical trials of medical devices shall include the following:
(1) the type of disease tested, the total number of cases and the gender and age of the cases, grouping analysis, and the setup of the control group (if necessary);
(2) the methodology of the clinical trial;
(3) the statistical methodology and evaluation methodology adopted;
(4) Clinical evaluation criteria;
(v) Clinical trial results;
(vi) Clinical trial conclusions;
(vii) Adverse events and side effects found in the clinical trial and their treatment;
(viii) Analysis of clinical trial effects;
(ix) Indications, scope of application, contraindications and precautions;
(x ) Problems and suggestions for improvement.
Article 27 of the medical device clinical trial information should be properly preserved and managed. Medical institutions shall save clinical trial information to five years after the termination of the trial. Implementers should save the clinical trial information to the final production of the product into use after ten years.