Medical devices on the market need to do what to prepare?

First identify your product is a few classes of medical devices has been a new enterprise example:

Products after the completion of research and development to send the type inspection specific inspection time depends on your product to do what projects in addition to the performance requirements of the source and electrical safety and electromagnetic compatibility whether there is biocompatibility testing, etc. No rectification of the case of general performance plus electrical safety takes about one month electromagnetic compatibility general three months biological compatibility time varies from one month to half a year depending on your project

The inspection time to obtain a report to decide whether to do clinical trials this time also depends on the product situation. Compatibility time varies from one month to half a year depending on the project you want to do

The test report is obtained according to the product to decide whether to do clinical trials This time is also not certain Diagnostic equipment is relatively simple and fast Therapeutic equipment is more troublesome time is also long Specifically, the time ranges from two or three months to a few years

Registration declaration of the second category in the provincial bureau of the third in the State General Administration of Technical Review The more smooth two types of one year time three types of one and a half years

Registration physical examination After the completion of the technical review of the provincial evaluation center unified organization of the physical examination to the limit of one rectification generally take one to two months

Administrative approval The evaluation center will be forwarded to the provincial bureau or the State General Administration of the materials to the certificate does not have a problem generally about a month to obtain the certificate of registration

Production license to submit the materials to apply for a production license if exempted, the general situation is that the production license will not be issued to the public. License If the physical examination is exempted from the case generally one month to two months to obtain the license