(1) "Medical Device Business License Change Application Form" in two copies;
(2) "Medical Device Business License" original, original copy;
(3) a copy of the business license;
(4) change of business (4) change the name of the enterprise, need to provide the administrative department for industry and commerce issued the "notice of approval of the change of enterprise name";
(5) change the legal representative, need to provide shareholders' resolutions, personnel appointment and removal decision and a copy of ID card;
(6) change the person in charge of the enterprise, need to provide the decision on the appointment and removal of personnel, resume, copy of ID card;
(7) change of the quality manager, need to provide the new quality manager appointment letter. (7) change the quality management, need to provide the new quality management letter of appointment, resume, copies of academic and qualification certificates, copies of identity cards;
(8) change the registered address, need to provide floor plan and proof of property rights or the right to use the house, geographic location maps and storage conditions;
(9) change the address of the warehouse, need to provide floor plan, proof of property rights or the right to use the house, the warehouse facilities and equipment directory (Reduction of the warehouse, do not need to provide the information required under this item);
(10) change the scope of business, should be submitted at the same time to operate a copy of the product registration certificate and the corresponding storage conditions (reduction of the scope of business, do not need to provide the information required under this item);
(11) applicant for the authenticity of the materials submitted to the self-assurance statement.