The opening of the second class of medical device manufacturers must have the following conditions:
(a) The person in charge of the enterprise should have secondary education or above, or junior title.
(B) the person in charge of the quality inspection organization should have a college degree or above, or intermediate title or above.
(C) the enterprise should occupy the corresponding proportion of the total number of employees above the junior title of engineering and technical personnel.
(d) the enterprise should have the appropriate product quality inspection capabilities.
(E) should be compatible with the production of products and scale of production, warehousing sites and environment.
(F) has the appropriate production equipment.
(vii) The enterprise shall collect and save the laws, regulations, rules and relevant technical standards related to the production and operation of the enterprise.
(viii) the production of sterile medical devices, should have a production site in line with the provisions.
Opening the second and third class of medical device manufacturers, should be to the enterprise's location in the provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department to apply, fill out the "Medical Device Manufacturer License (start-up) Application Form" (see Annex 2 of these measures), and submit the following materials:
(a) legal representative, the person in charge of the enterprise's basic information and proof of qualifications (ii) Notification of pre-approval of the name of the proposed enterprise issued by the administrative department for industry and commerce;
(iii) Documents proving the production site;
(iv) Resume, academic qualifications or title certificates of the persons in charge of the production, quality and technology of the enterprise; registration form of relevant professional and technical personnel and skilled workers with the departments and positions; and table of the ratio of senior, intermediate, and junior Ratio of technical personnel table;
(v) the scope of products to be produced, varieties and related product profiles;
(vi) the catalog of major production equipment and inspection equipment;
(vii) the catalog of production and quality management documents;
(viii) the proposed production of products, process flow diagrams, and indicate the main control items and control points;
(ix) Production of sterile medical devices, should provide production environment test report.
The applicant shall be responsible for the authenticity of all contents of its application materials.
Legal basis:
"Rules for the Classification of Medical Devices"
Article VI Classification of medical devices shall be classified according to the Medical Device Classification Judgment Table. In the following cases, the classification shall also be combined with the following principles:
(1) If two or more classifications are applicable to the same medical device, the classification with the highest degree of risk shall be adopted; the classification of a medical device package consisting of more than one medical device shall be the same as that of the medical device with the highest degree of risk in the package.
(ii) can be used as an accessory medical device, its classification should be comprehensive consideration of the accessory to the supporting body of the impact of medical device safety, effectiveness; if the accessory to the supporting body of the medical device has an important impact, the classification of the accessory should be no less than the supporting body of the classification of medical devices.
(C) monitoring or influence the main function of the medical device, its classification should be consistent with the classification of the medical device being monitored and influenced.
(D) the role of medical devices to the main combination of medicinal products, in accordance with the management of Class III medical devices.
(E) can be absorbed by the body of medical devices, in accordance with the third class of medical devices management.
(F) have an important impact on the medical effects of active contact with the human body devices, in accordance with the third class of medical devices management.
(vii) Medical dressings are managed in accordance with Class III medical devices if they are: expected to have the function of preventing the adhesion of tissues or organs, used as artificial skin, in contact with the deep dermis or the tissue below it for damaged wounds, used for chronic wounds, or can be absorbed by the body in whole or in part.
(viii) Medical devices supplied in sterile form shall be classified no lower than Class II.
(ix) by pulling, bracing, twisting, pressure grip, bending and other modes of action, the active application of sustained force on the human body, can be dynamically adjusted to the fixed position of the limbs of the orthopedic devices (excluding only fixed, supportive role of the medical device, nor with the surgical operation for temporary orthopedic medical devices or post-surgical or other treatments for the orthopedic limbs of the medical device), its Classification shall be not less than Class II.
(J) medical devices with measurement and testing functions, its classification should not be lower than Class II.
(xi) If the intended purpose of the medical device is clearly for the treatment of a disease, its classification should not be lower than Class II.
(xii) Passive reusable surgical instruments used to complete surgical operations such as clamping, cutting tissue or stone removal under endoscopy are managed in accordance with Class II medical devices.