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    Medical Device Testing Institution Qualification Accreditation Assessor Training Course Held

    Apr 25,2022

      To implement the "three-fixed" functions of the State Food and Drug Administration (SFDA), standardize the qualification accreditation management of medical device testing institutions, and strengthen the construction of the medical device testing institution qualification accreditation assessor team, the Science and Technology Standards Department of the SFDA held a training class for medical device testing institution qualification accreditation assessors in Changchun, Jilin Province from July 30 to August 1, 2013. The training content included laboratory quality management systems, electromagnetic compatibility testing methods and testing capabilities of medical devices, on-site assessment methods and techniques for medical device testing institution qualification accreditation, and workflow of medical device testing institution qualification accreditation. Professional and technical personnel, including quality managers and technical managers from 44 medical device testing institutions nationwide that have obtained qualification accreditation, participated in the training.

      During the training class, the Science and Technology Standards Department also organized a special seminar on the construction of the medical device testing and inspection system, listening to opinions and suggestions on aspects such as the construction of the medical device testing system, the formulation of qualification accreditation conditions for medical device testing institutions, the qualification accreditation of medical device re-inspection institutions, and the standardized management of medical device testing institutions.

      Through this training, the knowledge and abilities of the trainees in the qualification accreditation assessment work of medical device testing institutions were effectively strengthened, laying a foundation for further standardizing the qualification accreditation work of medical device testing institutions and promoting the construction of the medical device testing and inspection system.