Medical equipment, clinical trials, accreditation, change, record management
The medical institution of clinical trial management and record methods are being developed, the relevant administrative measures before the introduction of medical equipment to carry out clinical trials, the sponsor should choose the drug clinical trial machine food and Drug Administration in conjunction with the national health and Family Planning Commission identified the structure; the development of in vitro diagnostic reagents for clinical trials, in accordance with the "the food and Drug Administration on the implementation of the" medical devices registration management measures "and" in vitro diagnostic reagent registration management measures "related matters notice" (food and drug administration tube 2014 No. 144) the relevant provisions of the implementation of. Prior to this, according to the "medical device clinical trial institutions accreditation management approach" (Draft) stipulates: "the state medical equipment clinical trials institutions accreditation and regular review system.". Medical device clinical laboratory accreditation forms are divided into three categories: first qualification, professional qualification and continuous qualification. The qualification accreditation institution of clinical trial of medical devices (hereinafter referred to as qualification) refers to medical institutions qualification management departments in accordance with the statutory requirements for clinical trials of medical devices to the application (hereinafter referred to as the applicant) for clinical trials of medical devices have facilities (equipment and facilities, research personnel and technical ability, participants, organization etc.) management ability (management mechanism, management system, standard operating procedures, etc.) to evaluate the system of ethics review ability, make its bear medical device clinical trial qualification decision process. In the first stage of data review and on-site inspection of the applicant, the provinces, autonomous regions and municipalities directly under the food and drug administration shall apply for a data, data review, on-site inspection and comprehensive evaluation opinions of preliminary examination opinions submitted to the State Food and Drug Administration will be in after the completion of the trial. After receiving the information from the General Administration, the General Administration made a conclusion with the Wei Planning Commission on the audit results. Change to record management, qualification is simplified, the time required should be reduced, which is a good news for clinical institutions. Of course, the specific management methods have not yet been introduced, and everything remains to be seen.