Theoretically speaking, from the product registration test sent to the beginning of counting, free of clinical products usually 1 year - 1.5 years to get the registration certificate. This is one of the products to be able to successfully pass the test, the factory's system should not have repeated rectification, the quality of the collected literature is also very critical. For active products, some of the rectification will involve product structure changes, or software adjustments, then the rectification cycle may be longer, here depends on the experience of engineers. The quality of the literature and whether the physical examination is easy to pass, all test the professional as well as the rich experience of the registered regulatory personnel registration.
If clinical trials are required, then the difference according to the product is huge, from 1.5 to 3 years or even longer. The length of the cycle and the success of the approval, the professionalism, communication and coordination skills, and experience of the regulatory and clinical staff play a very important role. If your company does not have a team to do this registration, it is necessary to find a professional agency to intervene as early as possible.