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Product Register in China

When planning the entry of a determinate product on the chinese market, it is important to seek immediately, the support of a specialized company in the regulatory area. To do this, we present the Passarini Regulatory Affairs, a company of the regulatory branch that has office in Beijing and is able to help you get the registration of your product with the CFDA.

Our consultants work directly with the CFDA, in the implementation process and submission of regulatory documents, providing advisory on regulatory issues, and providing the entire structure for obtaining approval of your record in China.

Let the Passarini Regulatory Affairs help you with the below questions about Chinese regulations for medical products:

    • Documents Translation;
    • Obtainment the CCC mark, if applicable;
    • Execution of standard dossier for product registration;
    • Product Classification;
    • Development of clinical protocols to proof the effectiveness and safety;
    • of the device classification;
    • Determination of the best route to the approval with the CFDA in China;
    • Inspections of CFDA and renewal of product registration.

Contact us for more information about how to obtain your product approval registration with the CFDA in China.