What are the second-class medical devices?

X-ray filming machine, B-ultrasound, microscope and biochemical instrument belong to Class II.

The second category refers to medical devices whose safety and effectiveness should be controlled.

The establishment of second-class medical device manufacturing enterprises must meet the following conditions:

(a) the person in charge of the enterprise should have a technical secondary school degree or above or a junior title.

(two) the person in charge of the quality inspection institution shall have a college degree or above or an intermediate title or above.

(three) the engineering and technical personnel with junior titles or above in the enterprise shall account for the corresponding proportion of the total number of employees.

(four) enterprises should have the corresponding product quality inspection ability.

(five) there should be a place and environment for production and storage that match the products and scale of production.

(6) Having corresponding production equipment.

(seven) the enterprise shall collect and keep the laws, regulations, rules and related technical standards related to the production and operation of the enterprise.

(eight) the production of sterile medical devices should have a production site that meets the requirements.

Extended data

To start a second or third class medical device manufacturing enterprise, an application shall be submitted to the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the enterprise is located, and the Application Form for License (Start-up) of Medical Device Manufacturing Enterprise shall be filled out (see Annex 2 of these Measures), and the following materials shall be submitted:

(1) Basic information and qualification certificates of the legal representative and the person in charge of the enterprise;

(2) Notice of pre-approval of enterprise name issued by the administrative department for industry and commerce;

(3) Certification documents of the production site;

(four) the resume, education or professional title certificate of the person in charge of production, quality and technology of the enterprise; Registration forms of relevant professional and technical personnel and skilled workers, and indicate their subordinate departments and posts; Proportion table of senior, middle and junior technicians;

(5) The product range, varieties and related products to be produced;

(six) the main production equipment and inspection equipment directory;

(7) Catalogue of production quality management documents;

(eight) the process flow chart of the product to be produced, and indicate the main control items and control points;

(nine) the production of sterile medical devices, it shall provide the production environment test report.

The applicant shall be responsible for the authenticity of all the contents of his application materials.

References:

Baidu encyclopedia class ii medical equipment