1, the person in charge of the enterprise should have secondary education or junior title or above;
2, the person in charge of the quality inspection agency should have tertiary education or intermediate title or above;
3, the enterprise should occupy the corresponding proportion of the total number of employees of the title of junior engineering and technical personnel;
4, the enterprise should have the appropriate product quality inspection capabilities;
5, there should be production and storage sites and environments to match the products produced and the scale of the production.
4, the enterprise should have the corresponding product quality inspection capacity;
5, should be matched with the production of products and scale of production, warehousing 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, rules and regulations and related technical standards.
What is the process of registering a medical device company
The process of registering a medical device company is as follows:
1, the area of the warehouse is more than 15 square meters, the area of the office 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 contributions To the industrial and commercial name check;
3, with the relevant materials for the "Notice of Acceptance" and "Medical Device Business Enterprise License";
4, to the Industrial and Commercial Bureau of registration.
Legal basis: "Chinese People's *** and the State Company Law" Article 23
The establishment of a limited liability company, shall have the following conditions:
(a) shareholders in accordance with the quorum;
(b) there are in line with the articles of association of the company's capital contribution of all the shareholders subscribed to the amount of capital;
(C) the shareholders *** with the formulation of the articles of association;
(D) have a company name, the establishment of organizational structure in line with the requirements of limited liability companies;
(E) have a company residence.