What are the requirements for medical device company registration

The medical device company registration process is as follows:

1. The warehouse area is greater than 15, the office area is greater than 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 relevant materials to apply for the "Notice of Acceptance" and the "Medical Device Business Enterprise License";

4. Register with the Industrial and Commercial Bureau.

Extended Information: Documents Required for the Notice of Acceptance:

1. After receiving the application for registration, the Trademark Office will first conduct a formal examination. The formal examination is mainly divided into three parts: the examination of the application documents, the examination of the trademark reproduction specifications, clear procedures and necessary instructions, and the classification examination (examination of the goods and services filled in).

2. If it is deemed that the examination procedures are complete and the application documents are filled in in accordance with the regulations, it shall be accepted, the application date and application number shall be confirmed, and a notice of acceptance shall be issued.

3. Generally, the issuance time of the acceptance notice is about 3-6 months, and the official website of the Trademark Office will display the detailed information and process of the trademark after the acceptance notice is issued.

Materials required for industrial and commercial registration:

1. The certificate (power of attorney) of the representative designated by all shareholders or the co-entrusting person and the copy of the work card or ID card of the entrusted person;

2. Notice of pre-approval of enterprise name;

3. The legal personality certificate of the shareholder or the identity certificate of the natural person;

4. Application for registration of the establishment of a corporate legal person signed by the chairman or executive director of the company;

5. Resolution of the shareholders' meeting (sealed by shareholders and signed by natural person shareholders);

6. Resolution of the board of directors (signed by all directors);

7. Articles of association (stamped by all shareholders), and the articles of association of the group (stamped by the members of the group) must also be submitted to the group's articles of association (stamped by the members of the group);

8. Documents indicating the names and addresses of the company's directors, supervisors and managers, as well as certificates of appointment, election or employment, including:

1) Letter of appointment (wholly state-owned);

2) Letter of appointment (seal of the appointing unit);

3) Proof of the chairman's board of directors or executive directors, directors, supervisors and managers of the company;

4) Copies of ID cards of directors, supervisors and managers of the company;

9. Capital verification report issued by a legally qualified capital verification agency; (After the implementation of the new company law on March 1, 2014, this document is no longer required for enterprises under the subscription system).

10. Proof of the company's domicile, and the lease agreement (with a copy of the property right certificate) must be submitted for the leased house;

11. In the company's business scope, if it is a project that must be submitted for approval according to laws and administrative regulations, the approval documents of the relevant departments shall be submitted;

12. If laws and administrative regulations stipulate that the establishment of a limited liability company must be submitted for approval, the approval documents of the relevant departments shall be submitted;

13. A full set of registration** and other materials issued by the Bureau.

If you still have questions about this issue, it is recommended that you organize the relevant information and communicate with a professional in detail.

To operate medical devices, you first need to apply for a medical device business license, and secondly, you need to apply for an industrial and commercial business license. The medical device business license has certain regulations for the site and personnel, so it is better to consult a professional medical device consulting company. 1.

According to the requirements of the State Bureau for on-site inspection and acceptance of medical device business enterprises, establish and improve the organizational structure of the enterprise, and assist the enterprise in training on medical device regulations and practical operation. 2.Inspect the existing hardware of the enterprise, and jointly formulate the hardware rectification plan and engineering design plan with the enterprise according to the requirements of the "National Medical Device Business Enterprise On-site Inspection and Acceptance Standards".

3.Install the software management system and assist the enterprise to complete the preparation of quality management system documents. 4.

Provide samples or templates of application materials to guide enterprises to complete the preparation of application materials. 5.Submit an application for license inspection to the drug regulatory department and follow up until the medical device business license certificate is obtained.

6.Handling of industrial and commercial business licenses. There may be some differences in the details of this requirement in different regions.

The most certain way is to directly find the ** of your provincial food and drug administration to find the relevant requirements. The general process is: confirm the category of equipment that needs to be operated--- determine whether to apply to the municipal bureau or the provincial bureau according to the different categories--- find the content required to submit by the operating company--- prepare materials according to the requirements--- submit the application --- approved.

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

1. The conditions required for a registered medical device limited imitation company are as follows:

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

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, the following conditions shall be met:

1) The shareholders meet the quorum;

2) The amount of 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.

1. What are the conditions for a registered medical device company?

1. A registered medical device company must meet the following conditions:

1) Shareholders meet a quorum;

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

3) The 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.

To establish a company, an application for establishment registration shall be made to the company registration authority in accordance with the law. If the establishment conditions stipulated in this Law are met, they shall be registered as a limited liability company or a stock company by the company registration authority; If it does not meet the establishment conditions stipulated in this Law, it shall not be registered as a limited liability company or a share****.

2. Legal basis: Article 10 of the Administrative Measures for the Registration of Medical Devices.

The personnel handling the registration or filing of medical devices shall have corresponding professional knowledge and be familiar with the laws, regulations, rules and technical requirements of medical device registration or filing management.

2. What is the registration process for medical device companies?

1. The founder needs to go to the industrial and commercial department to process the pre-approval notice of the company name;

4. The founder submits written application materials, and once approved, a medical device enterprise license will be issued;

5. The founder opens a capital verification account, the shareholder contributes capital, and the accounting firm reports related to the capital verification;

6. The founder applies for a business license;

7. Go to engrave the company's required seal and prepare for business;

8. Transfer to the relevant departments to deal with the organization's ** certificate;

9. The personnel of the registered medical device company shall apply for the tax registration certificate to the relevant departments.