How To Determine The Orthodontic Bracket Belong To Products Listed In The “Catalogue Of Medical Devices Exempted From Clinical Trials”?


The orthodontic bracket is generally made of metal, porcelain or polymer material, and is used to bear and transfer the orthopedic force of orthopedic wire in orthodontic treatment. It belongs to products listed in the “Catalogue of Medical Devices Exempted from Clinical Trials” (hereinafter referred to as the Catalogue), but the products which are made of new materials, with new technologies, new designs or have new mechanisms of action and new functions are excluded. In the process of clinical evaluation, it is necessary to submit the comparison data of the product related information with contents described in the Catalogue, a comparison description of this product and the predicate products which have been available in Chinese market as well as the corresponding supporting documents. If the above-mentioned documents can prove that this product is equivalent to products listed in the Catalogue, it is exempted from clinical trial; if not, it is necessary to perform clinical evaluation in accordance with the “Technical Guidance for Clinical Evaluation of Medical Devices”.