I have shared with you different medical device products, how they change to register, etc., and today I will talk to you about some basic knowledge of surgical mechanical heart valve products in the registration.
First of all, let's talk about what a surgical mechanical heart valve is
Surgical mechanical heart valve is a class III medical device used for heart valve disease. It is made of metal, carbon fiber, or other materials and has a structure and function similar to that of a heart's natural valves.
Surgical mechanical heart valves are generally divided into two types: spherical valves and leaflet valves. A spherical valve is made up of one or more spherical structures that can be placed in the aorta or mitral valve position. A leaflet valve is made up of a series of blades that can be placed in the aorta or mitral valve.
Then we're talking about how the product can be registered as a medical device
Because the product belongs to the third class of medical device products, the competent authority is the State Food and Drug Administration. Teachers can register through the window (bring documents);Online (upload the information to the official website ERP system);By mail, etc.
The whole registration process is roughly divided into:1.Submission of application: First, it is necessary to submit an application for registration to the relevant medical device regulatory authority, including product technical specifications, clinical trial data, etc. 2.Review and Evaluation: Medical device regulators review and evaluate submitted applications to determine whether the safety and efficacy of the product meets the relevant standards and requirements. 3.Clinical trials: If a product passes the initial review, clinical trials are required to verify its safety and efficacy. Clinical trials are usually divided into three phases: the first phase is a small-scale trial, the second phase is a medium-sized trial, and the third phase is a large-scale trial.
4.Outcome report: After completing the clinical trial, it is necessary to submit a report of the results to the medical device regulatory agency, including the trial design, data analysis, conclusions, etc. 5.Approved for marketing: If a product has passed all reviews and evaluations, and clinical trial results demonstrate its safety and efficacy, then it can be approved for marketing.
The application materials to be submitted are:1Product technical documents: including product manuals, structural drawings, working principle drawings, etc. 2.Clinical Trial Report: A clinical trial must be conducted and complete trial data and results provided. 3.Production license certificate: The production license certificate issued by the National Medical Products Administration must be obtained. 4.Quality management system certification: must pass ISO9001 and other related quality management system certification. 5.Medical device registration certificate: A medical device registration certificate issued by the National Medical Products Administration must be obtained. 6.Business license of enterprise legal person: A copy of the valid business license of enterprise legal person must be provided. 7.Other relevant supporting documents: such as product test report, production process flow chart, etc.
Surgical mechanical heart valvesWhat to pay attention to when conducting clinical trials
When applying for the registration certificate, our products are subject to clinical trials according to national requirements, and we should also pay attention to the following links in the experiments.
1.Study design: We first need to consider how many samples are neededHow to do the experiment?It is also necessary to consider the settings of the experimental group and the control group, as well as the time point and follow-up time of the experiment.
2.Ethics review: This is a major matter involving human trials, and it needs to be approved by the ethics committee. In the process of experiments, you must abide by the relevant ethical norms and laws and regulations, and you can't mess around!
3.Patient selection: The selection of experimental subjects is not random, but must consider factors such as the patient's condition, age, and gender. It is also necessary to explain the purpose, methods, risks and benefits of the experiment to the patient, and obtain their consent before proceeding.
4.Data collection and management: During the experiment, the data must be collected accurately, completely, and in a timely manner. Electronic medical record systems or other tools can be used to automate the recording and management of data, saving time and effort.
5.Result analysis and reporting: After the experiment, the data should be statistically analyzed and the results interpreted, and then an experiment report should be written. The report should include the purpose, methods, results and conclusions of the experiment, and must also comply with academic norms and requirements.
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