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  • 1.The key documents for Medical Device CFDA registration (Class I)

    (1) The product risk analysis of information

    (2) The product technical requirements

    (3) The product test

    (4) Clinical evaluation data

    (5) Manufacturing information: an overview of the production process-related situations.

    (6) Product brochures and smallest sales unit packaging, label design comp

    (7) Certificates:

    1) Country of Origin Production Qualification

    2) Marketing Certification by the Original Country.

    (8) Compliance Statement

    2.Flow Chart of CFDA Approval


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