How much does the transfer fee for a Class II medical device manufacturing license usually cost?

Hello, in fact, the Class II medical device manufacturing license transfer this statement, a little strange, because the content and provisions of the medical device manufacturing license contains a lot of things and conditions, such as plant, personnel, equipment and so on. If you are transferring these to the next enterprise you only need to apply for a change of registration, if the main personnel, plant, equipment and so on have changed you need to carry out a change of registration, you need to re-apply for inspection to the Pharmaceutical Supervision Bureau.

The second class, the third class of medical device manufacturers

(a) production, quality and technical personnel should have the production of medical devices and the production of appropriate professional competence, and master

State supervision and management of medical devices and the laws, rules and regulations, as well as related product quality, technical regulations. The person in charge of quality shall not

simultaneously serve as the person in charge of production;

(b) the proportion of technical personnel with junior title or technical secondary education or above in the enterprise shall be compatible with the production of products

requirements;

(c) the enterprise shall have the production of products and production scale of the production of equipment, production, warehousing sites and environment. Enterprises

Enterprise production of medical devices have special requirements for the environment and equipment, should be in line with national standards, industry standards and relevant state regulations;

(d) the enterprise should set up a quality inspection organization, and with the production of varieties and production scale of the quality inspection capabilities;

(e) the enterprise should be preserved with the production and operation of medical devices related to laws, regulations, rules and regulations and relevant technical standards. (E) the enterprise shall keep and medical device production and operation of relevant laws, regulations, rules and relevant technical standards.

The opening of the third class of medical device manufacturers, in addition to the above requirements should be met, should also have the following conditions:

(a) in line with the quality management system requirements of the internal auditor of not less than two;

(b) the relevant professional title above the intermediate level or college education of not less than two full-time technical staff.

To start the second, third class medical device manufacturer, should fill out the "Medical Device Manufacturer License (start-up) Application Form"

and submit the following materials:

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

(b) industrial and commercial administration department issued a notice of pre-approval of the name of the proposed enterprise ;

(iii) 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; the ratio of senior, intermediate and junior technicians in the table;

(v) the scope of the products to be produced, varieties and related products;

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

(VII) the production of quality management documents catalog;

(VIII) the proposed production of products and process flow diagrams, and indicate the main control items and control points;

(IX) the production of sterile medical devices, should provide the production of environmental testing reports.

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