Who do medical politics hair (2009) 136

Provinces, autonomous regions, and municipalities directly under the TingJu health, xinjiang production and construction corps health:

To further strengthen medical equipment management, guarantee product clinical trial of medical quality and the safety of medical treatment, patient rights, according to the maintenance of medical devices, the regulations of the supervision and administration of medical devices clinical trial provisional regulations"

And other relevant provisions of medical institutions, clinical medical products related problem notification is as follows:

A medical institution shall be implemented strictly in accordance with the relevant provisions of the state, the plan approved in medical products clinical trial. After the completion of the trial should truthfully report issued by clinical trial.

Second, the medical institutions for medical research, development, production, management enterprise trial before the products, medical devices shall be issued to the "practice license of medical institution" and report to the administrative department of health. The program fails to perform the report without authorization and develop medical products clinical trial.

Third, the medical institutions and medical products, before clinical trial subjects or its guardian must be fully informed consent, and related subjects or its guardian agrees to rear can implement. Develop medical products clinical trial to participants shall charge.

Four, medical equipment products in the process of clinical trial, the medical institution shall closely monitoring medical devices, to find the efficacy and safety of adverse events must take timely treatment measures, completes related records, timely in accordance with related regulations and protect subjects reported health and life safety.

Five, medical institutions accept medical equipment r &d, production, business enterprise donated medical equipment, must be in accordance with the relevant provisions of the donation. Medical institutions shall not purchase without the pharmaceutical supervisory and administrative departments of the registration of medical products, including the registration of clinical trial medical products.

Six, the medical institution violates relevant provisions in the clinical trial medical products, once discovered by the competent administrative departments of public health and medical organizations shall immediately suspend medical products, and the clinical trial for relevant personnel of responsibility, Medical institutions shall report issued by the corresponding trial.

Seven, the health administrative departments should strengthen medical institutions within the jurisdiction of the medical equipment products clinical trial supervision and guidance to happen, according to timely corrective violations and processing.

The racemeeting on August 2009