Businesses operating two or three types of medical devices reported to the Provincial Drug Administration for examination and approval, the issuance of "Medical Device Business License".
1, the provincial enterprises (registered with the Provincial Administration of Industry and Commerce) by the Provincial Drug Administration direct acceptance;
2, other enterprises, units by the municipal drug regulatory departments acceptance and acceptance of the initial review, qualified, written acceptance opinions and sign the initial review form submitted to the Provincial Drug Administration for approval.
Second, the reporting materials:
1, fill out the "Medical Device Business License" application form in a form of three (copies are invalid);
2, an application report;
3, the enterprise's self-check summary (against the "Guangdong Provincial Medical Devices Qualification Accreditation Rules" and "Guangdong Province, Guangdong Province, nuclear, replacement - acceptance criteria" requirements) 1;
4, the enterprise's initial review and acceptance, write a written opinion and sign the acceptance form to the Provincial Drug Administration for approval. p>
4, the enterprise (company) constitution and the latest capital verification report (renewal of the license to provide corporate balance sheet and profit and loss account) 1 copy;
5, business, warehousing premises property rights certificate or rental agreement and a floor plan 1 copy;
6, technology, maintenance staff list and its diploma, title certificate copies of each 1 (stamped with the official seal of the unit);
7, the municipal Drug Administration's detailed written preliminary examination and acceptance report 1 (except for provincial enterprises);
8, the management rules and regulations.
(1) Quality Responsibility and Veto System,
(2) Inbound Acceptance, Custody and Outbound Review System,
(3) Quality Analysis and Feedback System,
(4) Expiry 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, substandard, expiration date or obsolete medical device disposal reporting system, (10) health management system;
9, enterprise Name industrial and commercial pre-registration registration certificate or a copy of the "legal person business license" copy of 1;
10, on the authenticity of the information provided by the self-assurance statement.
Three, 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 organization or commissioned by the municipal drug regulatory authorities against the "Guangdong Provincial Medical Devices Business Qualification Accreditation 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 equipment rules, regulations and quality standards of the products operated by the medical device product registration certificate and other relevant information.
2, site inspection and acceptance of qualified, 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.
Four, reporting requirements
1, the application report should include: the economic nature of the enterprise, the main person in charge of the profile, departmental setup, branch setup, the main business area and the main sales target, the main business varieties, specifications, storage space and the surrounding environment.
2, business, warehousing space plan: business, warehousing space to show the length, width (meters), business layout and shelf layout location, location of fire fighting equipment, 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, specialty, technical title, company position, ID number.
4, all the declaration of information must be printed on a4 paper, and stamped with the enterprise, unit or higher competent unit seal, business name of the business pre-registration certificate or a copy of the legal person business license, technical and maintenance personnel certificate of graduation, title certificate, etc., the declaration of the unit should be noted in the copy of the word "copy and the original consistent with the" and stamped with the seal, in order to be bound in a booklet.
Fifth, other matters
Enterprises, units should be declared in accordance with the above procedures and requirements for approval, it is strictly prohibited to the person in charge of the gift, such as the demand or acceptance of property, please report to the Provincial Drug Administration Supervision Office.