The conditions for registering a medical device company are: the person in charge of the enterprise of the medical device company should have an educational level of secondary school or above or have a title of junior or above. Medical device companies should have with the scope of business in line with the technical engineering staff and quality inspection organization. The person in charge of the quality inspection organization shall have the title of intermediate or above or the academic level of junior college or above. Article 7 of the Measures for the Supervision and Management of Medical Device Businesses, engaged in the operation of medical devices, shall have the following conditions: (a) with the scope of business and the scale of operation of the quality management organization or quality management personnel, quality management personnel should have a nationally recognized professional qualifications or titles; (b) with the scope of business and the scale of operation of the operation and storage places; (c) with the scope of business and the scale of operation of the operation of the appropriate (C) with the scope of business and business scale appropriate storage conditions, all entrusted to other medical device business enterprise storage can not set up a warehouse; (D) with the operation of medical devices appropriate quality management system; (E) with the operation of medical devices appropriate professional guidance, technical training and after-sales service capacity, or agreed to provide technical support by the relevant organizations. Enterprises engaged in the operation of Class III medical devices should also have a computerized information management system that meets the requirements of quality management of medical device business, to ensure that the operation of the product can be traced. Encourage enterprises engaged in the operation of Class I and Class II medical devices to establish a computerized information management system that meets the quality management requirements for the operation of medical devices.
Legal Objective:Company Law
Article 23
Conditions for the Establishment of a Limited Liability CompanyThe establishment of a limited liability company shall be subject to the following conditions:
(a) the shareholders meet the quorum;
(b) there is in line with the provisions of the articles of association of the company of the amount of capital contributions contributed by all shareholders;
(c) the shareholders *** with the formulation of the provisions of the articles of association;
(c) the shareholders *** with the development of the medical device business. (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.