List of application documents:
Data number (1) Overseas IVD registration application form;
Data number (2) Certification of overseas manufacturers;
Data number (3) Certifying documents of foreign government authorities’ approval for the product to be marketed in the country (region) of origin;
Data number (4) Certifying documents of overseas manufacturer’s compliance of "GMP" in countries or regions of origin, or other QMS certification documents;
Data number (5) Copies of designated agent’s letter of entrustment /commitment, business license or institutional registration certificate (photocopy);
Data number (6) Copies of letter of entrustment /commitment of designated registration agent, business license or institutional registration certificate (photocopy);
Data number (7) A statement of authenticity of the documents submitted;
Data number (8) Summary data
Data number (9) Package insert
Data number (10) Intended product standards and its preparation explanations;
Data number (11) Registration testing report;
Data number (12) Research data for major raw materials;
Data number (13) The research data for main production technology and reaction system;
Data number (14) Analysis of performance evaluation data;
Data number (15) Determination of reference value (reference range);
Data number (16) Stability research data;
Data number (17) Clinical trials data
Data number (18) Production and self-test records;
Data number (19) Sample of packaging and labeling;
Data number (20) Quality management system evaluation report.
Application process diagram：
