(1) The person in charge of the enterprise should have a secondary school education or a junior title or above;
(2) The person in charge of the quality inspection organization should have a college education or a junior title or above;
(3) The engineer and technician of the enterprise with junior title or above should occupy the corresponding proportion of the total number of employees;
(4) The enterprise should have the appropriate product quality inspection capability;
(5) There should be production sites and environments that are compatible with the products produced and the scale of the production. ) The enterprise shall have the corresponding product quality inspection capacity;
(5) There should be with the production of products and scale of production, storage space and environment;
(6) With the corresponding production equipment;
(7) The enterprise should collect and save the production and operation of the enterprise and the laws, regulations, rules and relevant technical standards.
Registered medical device company required information:
1, all the shareholders on behalf of or *** with the specially designated proxy certificate (power of attorney) and a copy of the delegate's work permit or identity card;
2, enterprise name pre-approval notification letter
3, the shareholders of the certificate of legal personality or the identity of the natural person
4, the chairman of the company or executive director of the company signed the application for registration of the establishment of enterprise legal person
5, the resolution of the general meeting of shareholders (shareholders' seal, signature of natural person shareholders);
6, the resolution of the board of directors (signed by all the directors);
7, the articles of incorporation of the company (stamped by all the shareholders), the group limited company for the Group's Articles of Association (stamped by the members of the group);
8, the company's articles of association (stamped by the members of the group);
8, the company's name, name of directors, supervisors, manager, name, name of the director of the company, supervisor of the company, and the name of the manager. Directors, supervisors, managers, the name and residence of the documents and proof of appointment, election or employment. Including the following:
(1) letter of appointment; wholly state-owned);
)2) power of attorney (stamped by the commissioning authority);
)3) proof of appointment of the chairman of the board of directors of the company or the executive director, directors, supervisors, and managers of the company
)4) copies of the ID cards of the directors, supervisors, and managers of the company;
9. Capital verification by a statutory qualified Agency issued by the capital verification report ( March 1, 2014 after the implementation of the new Companies Act, the appointment system enterprises no longer need this document )
10, unit address certificate, rental housing must be equipped with a lease agreement (copy of the ticket);
11, the company's scope of business, subject to the approval of the project shall be reported to the provisions of the laws, administrative regulations, the submission of the relevant departments to approve the document;
12, laws and administrative regulations require the establishment of a limited liability company subject to approval, submit the relevant departments to approve the documents;
13, the Bureau issued a full set of registration forms and other information.
The process of registering a medical device company:
1. The founders need to go to the business administration department to deal with the pre-approval notice of the company name.
2. To register a medical device company, you need to submit online application materials to the local Food and Drug Administration website.
3. Once the founder's online material review is approved, the local drug regulatory authority will schedule an appointment to view the business site.
4. The founders submit written application materials, and once approved, a medical device business license will be issued.
5. The founders to open a capital verification account, shareholder contributions, accounting services related to the capital verification report.
6. Founders apply for a business license.
7. To carve the company required, ready for business.
8. Transferred to the relevant departments to deal with the organization code certificate.
9. Registered medical device companies to the relevant departments to apply for tax registration certificate.
The above is the condition of registered medical equipment company, today Zhishuo editorial sharing is here, if you still have any questions about the conditions of registered medical equipment company, welcome you to contact Shanghai Zhishuo Enterprise Management Group Co.
Shanghai Zhishuo Enterprise Management Group Co.