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 (copy);

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 standards declared by the applicant;

Medical device product registration certificate (copy);

Summary of the whole process of product production, description of product production process, special process and key process;

Product sales and user feedback in the past three years;

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.

Note: The applicant's declaration refers to the product standard indicated on the product or its packaging or on the product's declaration, quality certificate, packing list, delivery note, and label.