Decision of the State Council on Revising the Regulations on the Supervision and Administration of Medical Devices
Decision of the State Council on Revising the Regulations on the Supervision and Administration of Medical Devices
Decision of the State Council on Revising the Regulations on the Supervision and Administration of Medical Devices
Order of the State Council of the People's Republic of China No. 680
May 4, 2017
The Decision of the State Council on Revising the Regulations on the Supervision and Administration of Medical Devices is hereby promulgated and shall come into force on the date of promulgation.
Premier: Li Keqiang
Decision of the State Council on Revising the Regulations on the Supervision and Administration of Medical Devices
The State Council decided to make the following revisions to the Regulations on the Supervision and Administration of Medical Devices:
I. Article 18 is revised to read: Clinical trials for medical devices shall be carried out in the clinical trial institutions that possess corresponding conditions, according to the requirements of quality management standards on clinical trials for medical devices, and shall be filed with the food and drug supervision and administration department of the people's government in the province, autonomous region or municipality directly under the Central Government where the entity requesting for clinical trials is located. The food and drug supervision and administration department that accepts the filing for clinical trials shall report the filing to the food and drug supervision and administration department and health and family planning department at the same level of the place where the clinical trial institution is located.
"Medical devices clinical trial institutions implement the filing management. Conditions that shall be met, as well as the filing management measures and quality management standards on clinical trials for medical devices clinical trial institutions, shall be formulated and promulgated by the food and drug supervision and administration department of the State Council in concert with the health and family planning department of the State Council."
II.
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