First, prepare information.
The applicant needs to prepare relevant materials including product registration application form, product technical requirements, product quality control system, clinical trial report, packaging labels and instructions, product samples, manufacturing license certificate and product filing certificate, patent certificate, safety evaluation report, technical report, etc. , and filed as required.
Second, the principal-agent
Enterprises can choose to entrust a professional agency to handle the registration certificate, and the agency will assist enterprises to handle the registration certificate and be responsible for communication and coordination with the regulatory authorities. Agencies need to have knowledge of relevant laws and regulations, rich registration experience, perfect service system, good reputation and word of mouth.
Third, product filing.
Applicants need to complete the filing of medical device products on the website of the US Food and Drug Administration in China and submit relevant information, including basic information such as product name, model and specifications; Product production license, registration certificate and other relevant qualification certificates; Technical documents such as product technical data, manuals and labels; Product sales license and other relevant qualification certificates. Information of product manufacturers and distributors; Product clinical trial report, use feedback and other information.
Fourth, inspection and testing.
Applicants need to submit product samples to the designated testing institutions for inspection and testing, and the test results will directly affect the approval of the registration certificate. Testing institutions need to have legal professional qualifications and qualification certificates. Have advanced testing equipment and technical means. Testers have high professional skills and rich testing experience. Have good management and service capabilities.
Verb (abbreviation for verb) approval
When the application materials are fully prepared and the test results meet the requirements, the regulatory authorities will review the application materials and conduct on-site audits. After passing the audit, the regulatory authorities will issue a registration certificate before the products can be legally listed for sale.