Guideline for Technical Review of Posterior Spinal Internal Fixation System Registration
The purpose of spinal surgery is to correct spinal deformity, relieve pain, stabilize the spine and protect nerves. Posterior spinal internal fixation is one of the main treatments. The safety and effectiveness of the posterior spinal internal fixation system used in surgery directly affect the treatment effect. This Guideline aims at guiding registration applicants in preparation and writing of application dossiers for registration of posterior spinal internal fixation system products as well as providing reference for technical review authorities in reviewing application dossiers.
This Guideline is the general requirements for posterior spinal internal fixation system. The applicant shall determine whether specific contents in the dossiers are applicable according to specific product characteristics. If not, reasons and the corresponding scientific basis shall be explained and the contents of registration application dossiers shall be supplemented and detailed.
This Guideline is a guiding document for the applicant and reviewer which does not cover administrative matters involved in registration approval and is not to be enforced as a regulation. Other alternative approach that meets the regulatory requirements may also be adopted, but detailed research and verification documents shall be provided. This Guideline shall be used on the premise of complying with relevant laws, regulations, and standards.
This Guideline is formulated under the current regulations and standard systems as well as the present cognitive level; along with the constant improvement of regulations and standards as well as the continuous development of science and technology, this Guideline will also be modified timely.