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Circular on The Release of Recommended Paths for Clinical Evaluation of Related Products in Subcategories 11, 12, 13, 14, 15, 17, and 22 of Classified Catalogue of Medical Devices (No. 20 of 2022)

Circular on The Release of Recommended Paths for Clinical Evaluation of Related Products in Subcategories 11, 12, 13, 14, 15, 17, and 22 of Classified Catalogue of Medical Devices (No. 20 of 2022)

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  • Time of issue:2022-05-20
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(Summary description)

Circular on The Release of Recommended Paths for Clinical Evaluation of Related Products in Subcategories 11, 12, 13, 14, 15, 17, and 22 of Classified Catalogue of Medical Devices (No. 20 of 2022)

(Summary description)

  • Categories:News
  • Author:
  • Origin:
  • Time of issue:2022-05-20
  • Views:0
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In order to further guide registered applicants to determine the clinical evaluation path of specific products, according to the relevant provisions of the Regulations on The Supervision and Administration of Medical Devices, in accordance with the technical Guidelines for Deciding whether to Carry out Clinical Trials on Medical Devices and other normative requirements, Based on the review of the experience and the catalog of medical device classification of subdirectories 11 "medical instrument disinfection sterilization equipment", 12 "active implanted devices," 13 "passive implanted devices", 14 "note, care and protection equipment", 15 "patients carrying equipment", 17 "dental instrument", the 22 "clinical test instrument", intended use and product description The recommended path for clinical evaluation of specific products was proposed with examples of product names.
We hereby inform you.

Click here to get more information.关于发布《医疗器械分类目录》子目录11、12、13、14、15、17、22相关产品临床评价推荐路径的通告(2022年第20号) (cmde.org.cn)

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