The contents contained in one registration certificate shall comply with the requirements of ‘”Guidance of registration units division for medical device”. Whether it is able to add me to add models or accessories into the registration certificate of registered products depends on the difference between the new model and the original model, as well as the relevance between the new accessories and the original products. If the newly added models or accessories and registered products can be divided into the same registration unit according to the guidance, they can be added via the Change of Permission Items.
Sources: NMPA
