Author：MeCan Medical–ultrasound machine manufacturers
I. The contents of the registration certificate include the product name, model, specifications, structure and composition, scope of application, product technical requirements, production address of imported medical devices, etc. This class of changes belongs to the change of license items. The registration application should be submitted to the original registration department. Generally, technical review and administrative approval are required. If substantial changes occur, on -site assessment is required.
Second, the contents of the registration certificate include the name of the registered person and the residence, the name of the agent and the residence, the house number of the production address, etc. The change of this class is a change in the registration item and should apply to the original registration department for the filing of the change item
Third, the contents of the registration certificate include the production process and the content of the manual. This type of situation should be reported to the provincial pharmaceutical regulatory department where the provincial pharmaceutical regulatory department is located. Most provinces have implemented electronic declaration methods. However, the regulations of the application methods have different regulations. Generally, changes in production processes pass through major issues.