1, the person in charge of the enterprise shall have a college degree or above, or junior title or above.
2, the person in charge of the quality inspection organization should have college education or above or intermediate or above title.
3, the enterprise should occupy the corresponding proportion of the total number of employees above the junior title of engineering and technical personnel.
4, the enterprise should have the appropriate product quality inspection capabilities.
5, there should be with the production of products and the scale of production, warehousing sites and environment.
6, with the appropriate production equipment.
7, the enterprise should collect and save and enterprise production, business-related laws, regulations, rules and relevant technical standards.
8, the production of sterile medical devices, should have a production site in line with the regulations.
Materials required for the filing of Class II medical devices
According to the "Supervision and Administration of Medical Devices", engaged in the operation of Class II medical devices, the business enterprise should be located in the municipal food and drug supervision and management department for the record, fill out the Class II medical device business filing form, and submit the following information:
1, a copy of the business license;
2, the legal representative, the person in charge of the enterprise, the quality of the person in charge of the identity, education or title certificate copy;
3, organizational structure and departmental setup description; business scope, business mode description;
4, the business premises, warehouse address of the geographic location of the map, the floor plan, the documents of proof of ownership of the house or lease agreement (with documents of proof of ownership of the house) copy
5, business facilities, equipment catalog; business quality management system, work procedures and other documents catalog;
6, other supporting materials.
In short, to register a medical device company needs to meet numerous conditions, including registered capital, sites and facilities, professional and technical personnel, medical device registration certificate, product quality and safety and other aspects.
Legal basis:
"Chinese People's **** and State Company Law"
Article 7
Companies established in accordance with the law, the company registration authority shall issue the company business license. The date of issuance of the business license shall be the date of establishment of the company. Company business license shall contain the company's name, domicile, registered capital, business scope, the name of the legal representative and other matters. Changes in the company's business license, the company shall register the changes in accordance with the law, the company's registration authority to issue a business license.
Article 23
To establish a limited liability company, the following conditions shall be met:
(1) the shareholders meet the quorum;
(2) there is the amount of capital contributions paid in by all the shareholders in conformity with the provisions of the articles of association;
(3) the shareholders *** with the enactment of articles of association;
(4) there is a name of the company, and organizational structure in conformity with the requirements of a limited liability company is established;
(4) there is a name of the company; and Limited liability company requirements of the organizational structure;
(e) have a company residence.
"Supervision and Administration of Medical Devices"
Article 9
To engage 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 the relevant professional qualifications or titles;
(b) with the scope of business and the scale of operation of the appropriate quality management organization or quality management personnel, quality management personnel should have the relevant professional qualifications or titles;
(ii) with the business scope and scale of operation of the business premises;
(C) with the scope of business and scale of operation of the storage conditions;
(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 of the quality management organization or personnel.
Enterprises engaged in the operation of Class III medical devices should also have a computerized information management system that meets the requirements of the quality management system for the operation of medical devices, to ensure that the operation of the product can be traced. Encouraged to engage in the first class, the second class of medical devices business enterprises to establish a quality management system in line with the requirements of the medical device business computer information management system.