The scope of business does not include medical devices, can you operate Class II medical devices?

No, only after application can operate.

Opening the second class of medical equipment manufacturers must have the following conditions:

(a) The person in charge of the enterprise should have a college degree or above, or more than 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.

To start the second, third class 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 Manufacturing Enterprise License (start-up) Application Form", and submit the following materials:?

(a) the legal representative, the person in charge of the enterprise's basic information and proof of qualifications;?

(B) the administrative department for industry and commerce issued a notice of pre-approval of the name of the proposed enterprise;?

(c) documents proving the production site;?

(iv) Resume, education or title certificates of the person in charge of production, quality and technology of the enterprise; registration form of relevant professional and technical personnel and skilled workers with departments and positions indicated; and a table of the ratio of senior, intermediate and junior technical personnel;?

(e) the proposed scope of production products, varieties and related product profile;?

(F) the main production equipment and inspection equipment catalog;?

(vii) Catalog of production quality management documents;?

(viii) Process flow diagram of the products to be produced, with the main control items and control points;?

(ix) the production of sterile medical devices, should provide production environment test report.

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

Baidu Encyclopedia - Class II Medical Devices