The process of medical device registration in China is strict and complex, and it needs to go through multiple links and steps. Here's the detailed registration process:
Step 1: Prepare the application materials.
In the stage of preparing application materials, the applicant needs to prepare complete application materials in accordance with the requirements of the Administrative Measures for the Registration of Medical Devices issued by the State Food and Drug Administration. These materials include:
Product technical report: The report should include the technical principle, structural composition, performance indicators, safety evaluation and other information of the product.
Quality management system documents: The applicant needs to establish a quality management system suitable for the product and submit the corresponding documents.
Product samples: Applicants are required to provide product samples for testing and clinical trials.
Clinical Trial Report: The applicant needs to submit a completed clinical trial report to prove the safety and efficacy of the product.
Other relevant materials: Applicants also need to submit other necessary materials, such as enterprise qualification certificates, product instruction manuals, etc.
Step 2: Submit application materials.
The applicant needs to submit the application materials to the food and drug supervision and administration department of the province, autonomous region or municipality directly under the central government for preliminary review. The content of the preliminary review includes the review of the completeness, standardization and compliance of the application materials. After passing the preliminary examination, the applicant needs to revise and improve the application materials in accordance with the review opinions, and submit them to the State Food and Drug Administration for review.
Step 3: Technical review.
The State Food and Drug Administration will conduct a technical review of the application materials, including product technology, quality management system, clinical trials, etc. The technical review is carried out by a qualified technical review body, which will conduct a comprehensive analysis and evaluation of the application materials to determine the safety and effectiveness of the product. If the technical examination is unqualified, the applicant needs to make rectification and resubmit the application materials in accordance with the examination opinions.
Step 4: Approve and issue certificates.
If the technical review is qualified, the State Food and Drug Administration will issue a medical device registration certificate and publicize the relevant information. The medical device registration certificate is a necessary condition for the legal listing of medical devices, and medical devices that have not obtained the registration certificate shall not be marketed and used. After obtaining the medical device registration certificate, the applicant can carry out the sales and promotion of the medical device within the specified time.
It should be noted that each link in the medical device registration process has strict time limits and requirements, and applicants need to complete relevant tasks and submit corresponding materials within the specified time. At the same time, the State Food and Drug Administration will also conduct strict review and supervision of the application materials to ensure that the registration process is fair, transparent and legal.