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Imported/Domestic Medical Devices Registration

Renew of registration of domestic Class III medical devices

   Source��   outao

List of application documents:
Data number (1) Initial registration form for domestic Class III medical devices;
Data number (2) Medical device manufacturer certification;
Data number (3) The original registration certificates of medical devices;
Data number (4) product registration test report issued by medical device testing institutions;
Data number (5) Applicable product standards and instructions;
Data number (6) Product quality tracking reports;
Data number (7) Medical device manuals;
Data number (8) valid certifying documents for evaluation (certification) of production quality system - quality system evaluation report for specific product should be provided accordingly;
Data number (9) For circumstances described in Article 34 of the "Provisions for Medical Device Registration", the applicant shall provide the corresponding explanations and certifying documents;
Data number (10) Self-assurance statement of authenticity of the dossiers submitted;
Data number (11) Other issues.