Registering medical devices and IVDs in China can be complex and difficult. Even if you have deep FDA and EU registration experience, meeting requirements under China NMPA can be challenging. Plus, you must deal with the vast differences in Chinese culture and language.
By helping 250+ of manufacturer through this process, China Med Device team has established best practices that encourage collaboration, reduce snafus and expedite registration speed.
China RA Strategy & Consulting
Identify NMPA classification and registration composition units
Design Phase Consultation
Estimate registration costs and timeline
Provide reference NMPA regulations and materials
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