How to set up a branch office to deal in medical devices

To operate medical devices, if you open a branch in Zhengzhou, Henan, you must 1Apply for Zheng Zhou's business license 2When dealing in medical devices, comply with the articles of association of the parent company.

3.Law-abiding business 4Make more friends in business, taxation, etc., they may take care of you!!

1. What are the conditions required for the registration of medical devices?

1. The conditions required for the registration of medical devices are as follows:

1) The person in charge of the enterprise should have a technical secondary school degree or above or a junior professional title;

2) The person in charge of the quality inspection agency should have a college degree or above or an intermediate title or above;

3) The corresponding proportion of engineering and technical personnel with junior titles or above in the enterprise should account for the total number of employees;

4) Enterprises should have the corresponding product quality inspection capabilities;

5) There should be a production and storage site and environment that are matched with the products and scale produced;

6) Have the corresponding production equipment;

7) Enterprises should collect and keep laws, regulations, rules and relevant technical standards related to the production and operation of enterprises.

2. Legal basis: Article 23 of the Company Law of the People's Republic of China to establish a limited liability company shall meet the following conditions:

1) The shareholders meet the quorum;

2) There is a capital contribution subscribed by all shareholders in accordance with the provisions of the company's articles of association;

3) Shareholders jointly formulate the articles of association;

4) Have a company name and establish an organizational structure that meets the requirements of a limited liability company;

5) Have a company domicile.

2. What is the process of registering a medical device company?

The process of registering a medical device company is as follows:

1. The warehouse area is greater than 15 square meters, and the office area is more than 30 square meters, and the layout is in accordance with the requirements of the Food and Drug Administration;

2. Bring the name pre-approval application; The identity certificate of the investor, the registered capital and the proportion of capital contribution shall be checked by the industry and commerce;

3. Bring relevant materials to apply for the "Notice of Acceptance" and the "Medical Device Business Enterprise License";

4. Register with the Industrial and Commercial Bureau.

Depending on how many types of medical devices you are, the requirements for each category are different, and the following is an example:

Conditions for starting a medical device business enterprise:

1. Personnel: 1The quality full-time management personnel of the third class of medical device business enterprises shall have a college degree or above or an intermediate title or above;

2.The third class of medical device business enterprises shall not be less than 1 million yuan.

3.The quality inspection personnel of the third class of medical device business enterprises shall have a college degree or above or an intermediate title or above; 4.Enterprises that operate products involving retail household products or three types of implantable devices should be equipped with personnel with certain medical and technical qualifications.

2. Business premises.

1.Business site: the usable area of general enterprises is not less than 40 square meters, and residential buildings cannot be used as business premises of enterprises; The retail business must be a façade house;

2.Storage conditions: the usable area of general enterprises is not less than 20 square meters, and residential buildings cannot be used as storage places for enterprises;

3.Enterprises that operate special medical device products such as disposable sterile and implantable must have self-managed warehouses, and the storage conditions should meet the requirements of product standards.

The medical device company registration process is as follows:

1. The warehouse area is greater than 15, the office area is large and the chain is 30, and the layout is in accordance with the requirements of the Food and Drug Administration;

2. Bring the name pre-approval application; Proof of identity of the investor; The registered capital and the proportion of capital contribution shall be checked by industry and commerce;

3. Bring the relevant materials to handle the "Notice of Acceptance" and the "Medical Device Business Enterprise False License";

4. Register with the Industrial and Commercial Bureau.