To apply for medical device quality certification, the following materials should be submitted to the certification body:

  The application for product quality certification and the application for quality system certification signed by the authorized representative of the applicant;

   Business license or registration certificate of the applicant unit (photocopy);

   Quality manual of the applicant unit, and if necessary, provide the program documents of the enterprise;

   The product applying for certification or the product standard covered by the quality system;

  The applicant declares the implementation of the standard;

  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 and user feedback in the past three years; ISO13485

   List of main outsourcing and outsourcing parts;

  Other materials, such as corporate product catalogues, product introductions, product promotional materials, etc.; information on organizations and personnel who have provided certification consultation.