My organization wants to sell medical devices, is it necessary to apply for special approval? How to handle?

First, the approval of the authority to operate two or three types of medical equipment business enterprises reported to the provincial Drug Administration for examination and approval, the issuance of "medical equipment business enterprise license.　　1, the provincial enterprises (registered with the Provincial Administration of Industry and Commerce) by the provincial Drug Administration direct acceptance; 2, the other enterprises, units by the municipal drug regulatory departments to accept and initial acceptance, qualified, written acceptance and signed in the review form of the initial review of the opinions reported to the Provincial Products Regulatory Board for approval.　　Second, the reporting materials: 1, fill out the "Medical Device Business License" application form in three copies (photocopies are invalid); 2, an application report; 3, the enterprise self-examination summary (against the "Guangdong Provincial Medical Device Business Enterprise Qualification Accreditation Rules" and "Guangdong Province, Guangdong Province, nuclear, replacement - Acceptance Criteria" requirements) 1; 4, the enterprise (the company) articles of incorporation and the latest capital verification report (replacement of the provision of corporate balance sheet and income statement) 1 each. And profit and loss account) 1; 5, business, warehousing premises, property rights or rental agreement and a copy of the floor plan; 6, technology, maintenance staff list and their diplomas, title certificates, a copy of each (stamped with the official seal of the unit); 7, the city Drug Administration's detailed written acceptance of the initial examination report 1 (except for the provincial enterprises); 8, the various management rules and regulations.　 (1) quality responsibility and veto system, (2) warehousing acceptance, storage and out of the warehouse review system, (3) quality analysis and feedback system, (4) expiration date management system, (5) door-to-door sales quality management system, (6) special, imported medical devices management system, (7) after-sales service (installation, use of technical training, maintenance, repair, etc.) system, (8) implantation and special medical device quality Tracking and adverse reaction reporting system, (9) return, unqualified, expiration date or obsolete medical device disposal reporting system, (10) health management system; 9, business name of the industrial and commercial pre-registration of proof of registration or a copy of the "legal person business license" copy of a copy of the 10, the authenticity of the information provided by the self-assurance statement.　　Third, the approval process 1, the Provincial Drug Administration on the declaration of complete information and meet the requirements of the approval process before acceptance. The operator should be accepted within 15 working days from the date of acceptance of the organization's personnel or commissioned by the municipal drug regulatory authorities against the "Guangdong Provincial Medical Devices Qualification Accreditation Implementation Rules" for on-site acceptance. Acceptance includes: office, business, warehousing, maintenance sites, testing, maintenance equipment and installation and maintenance records, quality system implementation, technical staff on duty, business models and collection and preservation of medical devices, rules and regulations and the quality of the products operated by the quality standards, medical device product registration certificate and other relevant information.　　2, the site acceptance, within 10 working days to fill out the medical device approval form, put forward the first review of the views, according to the procedures reported to the Division, the Bureau of leadership for approval.　　Fourth, the reporting requirements 1, the application report should include: the economic nature of the enterprise, the main person in charge of the profile, departmental settings, branch settings, the main business areas and the main sales targets, the main business varieties, specifications, warehousing space and the surrounding environment.　　2, business, warehousing space plan: business, warehousing space to show the length, width (meters), business layout and shelving location, fire equipment location, five prevention facilities.　　3, technology, maintenance personnel list: is specifically referred to science and technology, medicine, pharmacy, engineering technicians, required to list the name, gender, age, last graduated from school, education, specialization, technical title, company position, identity card number.　　4, all declaration information must be printed on A4 paper, and stamped with the enterprise, unit or higher unit in charge of the official seal, the name of the enterprise business pre-registration certificate or a copy of the legal person's business license, technical and maintenance personnel graduation certificate, title certificate, etc., the declaring unit should be in the photocopy of the word "copy and the original in line with the words and stamped with the official seal, in order to be bound into a booklet.　　V. Other matters Enterprises, units should be approved according to the above procedures and requirements for the declaration, is strictly prohibited to the person in charge of gifts, such as the demand or acceptance of property, please report to the Provincial Drug Administration Supervision Office.