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Application for medical device quality certification should submit the following materials to the certification body:
Application for Product Quality Certification and Application for Quality System Certification signed by the authorized representative of the applicant;
Business license or registration certificate of the applicant(copy);
A quality manual for the applicant and, if necessary, a procedural document for the enterprise;
Product standards covered by the application for certification or quality system;
(a) The criteria for the applicant's declaration of enforcement;
Medical device product registration certificate(copy);
Summary of the whole process of product production, product production process and special process, key process description;
Product sales in the past three years and user feedback information; ISO 13485
List of main outsourcing and outsourcing contracts;
Other materials, such as product catalogues, product profiles, product publicity materials, etc.. Information on organizations and personnel who have been certified and consulted.



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