Class II Medical Device Registration Certificate Charges

The fee for a Class II medical device registration certificate is usually around **555 RMB/piece**. However, some organizations may charge a higher fee based on the difficulty of the process, the complexity of the process and other factors. The specific fee may vary depending on the type of product, processing difficulty, service content and other factors, which need to be inquired and confirmed according to the actual situation. At the same time, the amount of medical device registration fee also depends on the type of product and the situation, which can be generally divided into two parts: the state fee and the agency fee. National fee refers to the official fee for medical device registration, including application fee, inspection fee, evaluation fee, etc., which is different for different kinds of products. The agency fee refers to the service fee of entrusting the medical device registration agency with professional ability to assist in the registration, including consulting fee, writing fee, delivery fee, public relations fee, etc. There is no fixed standard for this part of the fee, and it will be different according to the level of the agency and the quality of service. Therefore, the cost of Class II medical device registration certificate agency fee is usually between 80,000 and 2 million, depending on the specific circumstances of the product and the choice of agency.