List of application documents:
Data number (1) Application form for registration of overseas medical device;
Data number (2) Medical device manufacturer certification;
Data number (3) Copies of the applicant’s business license, and the manufacturers letter of authorization to agents for registration;
Data number (4) Documents proving overseas medical device competent authorities’ approval or admission of entry into the market of the country (region);
Data number (5) Applicable product standards;
Data number (6) Medical device manuals;
Data number (7) Product registration testing report issued by institutions for medical device testing (for Class II, III medical devices);
Data number (8) Medical device clinical trial data;
Data number (9) Product warranty issued by the manufacturers
Data number (10) Manufacturer’s power of attorney designating Chinese agents, the agent's letter of commitment and business license or institutional registration certificate;
Data number (11) letter of entrustment designating after-sale agencies in China, and the agencies’ letter of commitment and qualification documents;
Data number (12) Self-assurance statement of authenticity of the dossiers submitted;
