The application process for Class II medical device registration certificate includes preparation of information, commissioning agent, product filing, inspection and testing, review and approval.
One, prepare the information
Applicants need to prepare, including the product registration application form, product technical requirements, product quality control system, clinical trial reports, packaging labels and manuals, product samples, manufacturing licenses and product filing certificates, patent certificates, safety assessment reports, technical reports, and other related materials. reports and other related materials, and filing and organizing according to the requirements.
Two, commissioned by the agent
Enterprises can choose to commission a professional agency for the registration certificate application, the agency will assist enterprises to apply for the registration certificate, and is responsible for communication with the regulatory authorities, coordination and other work. The agency needs to have knowledge of relevant laws and regulations, rich experience in registration, a perfect service system, and a good reputation and word of mouth.
Three, product filing
Applicants need to complete the medical device product filing on the China Food and Drug Administration website, submit the relevant information, including the product name, model, specifications, and other basic information; product manufacturing license, registration certificate and other relevant qualifications; product technical information, manuals, labels and other technical documentation Product sales license and other relevant qualification certificates. Product manufacturers, distributors and other information; product clinical trial reports, use of feedback and other information.
Four, inspection and testing
Applicants need to submit product samples to the designated testing organization for inspection and testing, the test results will have a direct impact on the approval of the registration certificate. The testing organization needs to have legal practice qualifications and qualification certificates. Have advanced testing equipment and technical means. High level of professional skills of testing personnel, with rich testing experience. Have good management and service capabilities.
V. Review and Approval
When the application materials are well prepared and the test results meet the requirements, the regulatory authority will review the application information and conduct an on-site audit. After passing the audit, the regulatory authorities will issue a registration certificate, the product can be legally marketed and sold.