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Trauhui participated in the 2014 Medical Device Supervision and Management Regulation Publicity Meeting
The Regulation on the Supervision and Administration of Medical Devices was passed by the State Council on December 28, 1999 and came into force on April 1, 2000. The new version of the "Regulations on the Supervision and Administration of Medical Devices" will be implemented on June 1, 2014. July 28, 2014 Changzhou Food and Drug Administration and Changzhou Medical Device Industry Association jointly organized a new version of Changzhou City, "Medical Device Supervision Regulations," publicity training class. Li Xintian, Deputy Director of Medical Devices Department of Jiangsu Food and Drug Administration, Yang Meng, Executive Vice President of Changzhou Medical Devices Industry Association and Huang Xiang, Director of Medical Devices of Changzhou Food and Drug Administration attended the opening ceremony.
Trauhui quality control manager and manager Zhou Yu attended the training. The training content is divided into two major parts: one is the new "Regulations on the Supervision and Administration of Medical Devices" and the new regulatory requirements after listing, and the second is the clinical evaluation requirements under the new registration system. Teaching using theoretical explanations, specific case analysis, on-site answering a combination of forms, training content close to the medical device production, operation, supervision of the actual.
The training deepens the understanding of the new "Regulations on the Supervision and Administration of Medical Devices" and is of great significance to standardizing the company's product development, production, quality management and operation. Under the new situation, both the challenges and opportunities coexist. The Company will strictly implement the requirements of the new laws and regulations, enhance the overall quality and safety standards, and ensure the healthy and orderly development of the Company.