Rights and Obligations of Medical Device Testing Institute


According to the <The Measures for Medical Device Inspection Institute Qualification Determination>, the inspection institutes are endowed with following rights and obligations:
Rights
  • Can advertise the inspection business and service scope to public;
  • Have the authorization to give the test report within their service scope;
  • Can raise the objection or appeal to CFDA;
  • Can terminate the qualification in own will.
Obligations
  • The inspection institute and staffs must be responsible for the confidentiality of tested products and cannot work for or participate in the development, manufacturing, distribution and technical consulting or medical device.
  • In the spot evaluation arranged by CFDA, the authorized inspection institute shall offer the necessary instrument and experiment as required, and bring convenience for document investigation, supervision, re-examination, experimental area and reference.
  • The authorized inspection institute shall take the qualification examination or laboratory comparison appointed by CFDA.
  • The authorized inspection institute shall be responsible for the test report. The authorized inspection institute shall process the feedback/problems from customers effectively, if the problem cannot be solved within two months, the institute must report the summary and process of the problem to CFDA.
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Ms. Louise Halpin
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