1, the conditions required for registration of medical devices limited company are as follows:
(1) the person in charge of the enterprise should have a secondary school education or junior title or above;
(2) the person in charge of the quality inspection organization should have a college education or intermediate title or above;
(3) the enterprise junior Above title engineers and technicians should occupy the corresponding proportion of the total number of employees;
(4) the enterprise should have the appropriate product quality inspection capabilities;
(5) should have with the production of products and the scale of production and warehousing sites and environment;
(6) with the appropriate production equipment;
(7) the enterprise should be collected and preserved and the enterprise's production, business-related laws, regulations, rules and relevant technical standards.
2, the legal basis: the Chinese people's *** and the State Company Law, Article 23
The establishment of a limited liability company, shall have the following conditions:
(a) the shareholders meet the quorum;
(b) there are in line with the articles of association of the company's capital contribution of all shareholders;
(c) the shareholders *** with the formulation of the company's articles of association ;
(d) have a company name, establish an organizational structure that meets the requirements of a limited liability company;
(e) have a company residence.
Two, what is the process of registering a medical device company
The process of registering a medical device company is as follows:
1, the warehouse area is more than 15 square meters, the office area is more than 30 square meters, and in accordance with the requirements of the layout of the Pharmaceutical Supervisory Bureau;
2, with the name of the application for pre-approval; the identity of the investor, the registered capital, the proportion of capital contribution to the industry and commerce to check the name;
2, with the name pre-approval; investors, identity proof, registered capital, capital contribution Proportion to the industrial and commercial name check;
3, bring the relevant materials for the "Notice of Acceptance" and "Medical Device Business Enterprise License";
4, to the Industrial and Commercial Bureau of registration.