Let Landlink-MED help you with China medical device regulatory issues:

  • Determine device classification.

  • Determine if clinical trials will be needed for your device.

  • Ascertain the best route to NMPA approval in China.

  • Compile the registration application and Technical Requirement document.

  • Coordinate product testing in China.

  • Prepare final submissions.

  • Handle NMPA Supplementary Notice requests (additional information inquiries from the DVDA) and device registration renewals.

  • FDA Services

    FDA 510(k) submissions, U.S. Agent Service - FDA
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  • CE Marking Services

    Authorized Representative,Free Sales Representative,Registration of Medical Devices in Europe
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  • NMPA Services

    help you obtain China Food and Drug Administration (NMPA) approval for your medical device or IVD

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Local based medical device experts, law and regulatory affairs professionals