What is the medical device company registration process? Can anyone help me?

Registered as a business or production company? I can help you.

What is the biotech company registration process? 1. Fill in the "Application Form for Pre-approval of Enterprise Name" and submit the application for name verification; 2. Receive the "Notice of Pre-approval of Enterprise Name", which means that the name of the company is decided; 3. Prepare pre-trial materials and submit them online, and after the online pre-trial is passed, the industrial and commercial counter submits the pre-trial materials; 4. The industrial and commercial issuance of a receipt, even if the pre-trial materials are no problem, wait for the review, and print the business license; 5. Obtain a business license; 6. Take the original business license to engrave the seal, generally the company's three chapters (legal person chapter, company chapter, financial chapter), and more will also engrave the company's contract special seal, invoice special seal; 7. Go to the bank with the original business license and seal to open the company's basic account and get the account opening permit; 8. The legal person and the company's financial personnel should go to the tax bureau to verify the tax (verified tax) with the original ID card and the original business license and official seal of the company

1.Company name.

2.Registered capital of the company.

3.Shareholder distribution ratio, list of legal persons and supervisors.

4.The original ID card of the shareholder and legal person, and the copy of the ID card of the supervisor.

5.Registered address of the company.

6.Scope of business.

7.If it accounts for one of the shareholders and supervisors (Bank of China, China Construction Bank, Agricultural Bank of China, Industrial and Commercial Bank of China, Ping An Bank), it shall be used as the signature of the registered company.

If it is in Shenzhen, we look forward to your consultation.

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.

Companies that register medical devices must first find a registered address, need to have a warehouse, and then verify a company name, first approve the medical device qualification, and then register the company.

After March 2014, the registered company implements the subscription system, which can be registered first and then contributed, and the capital contribution time can be written for 10 years or 20 years, which can be set according to your own situation.

1.Determine the name of the shareholder and the company, and pre-approve the name on the website of the Industrial and Commercial Bureau2After the name approval is passed, go to the name verification window of the Industrial and Commercial Bureau to receive the name approval notice 3After receiving the name approval notice, fill in the establishment registration online.

4.The establishment registration review is submitted by appointment.

5.On the appointment day, bring all the paper materials to the industrial and commercial bureau to submit.

The business license will be collected after working days.

7.Handle the engraving for the record.

8.Handling Agency**.

9.Apply for a tax registration certificate.

10.Local tax reports.

11.Open a basic account for the company.

12.National Tax Report, Purchase National Tax Tax Control.

If you don't know what you know, just ask

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.

Medical device company registration process 1, name verification: to the industrial and commercial bureau to get a "enterprise (trade name) name pre-approval application form", fill in the company name you are going to take, by the industrial and commercial bureau online (industrial and commercial bureau intranet) to retrieve whether there is a duplicate name, if there is no duplicate name, you can use this name, will be issued a "enterprise (trade name) name pre-approval notice". 2. Renting a house:

Go to a dedicated office building and rent an office. After renting a house, you must sign a rental contract and file it with the housing authority. 3. Prepare the "Articles of Association":

The bylaws need to be signed by all shareholders. 4. Engrave a private seal: (all shareholders) go to the place where the seal is engraved on the street to engrave a private seal, and tell them to engrave the private seal of the legal person (square).

5. Go to the industrial and commercial bureau to obtain all kinds of company establishment registration, including the application form for establishment registration, the list of shareholders (initiators), the supervision of directors and managers, the registration form of legal representatives, and the registration form of designated representatives or entrusted persons. After filling it out, submit it to the Industrial and Commercial Bureau together with the notice of verification, the articles of association, the rent contract, and the copy of the real estate certificate. It takes about 15 business days for the license to be issued.

6. With the business license, go to the company designated by the Public Security Bureau to engrave the official seal and financial seal. In the following steps, the official seal or financial seal is required. 7. After receiving the license, one of the materials required by the tax bureau is the accounting qualification certificate and identity certificate.

Of course, you can ask a **bookkeeping company** to do the accounting. 8. Go to the bank to open a basic account: Go to the bank to open a basic account with a business license.

9. Apply for purchase invoices: If your company sells goods, you should apply for invoices from the national tax, and if it is a service company, apply for invoices from the local tax. 3. Materials required for the registration of medical device companies a. The original ID cards of investors, legal persons and supervisors; b. Notice of pre-approval of enterprise name; c. Clarify the investment ratio of each investor; d. Determine the scope of business; e. Accounting ID card and qualification certificate; f. Other required materials.

Fourth, how many departments should be run for the registration of medical device companies (1) name check industrial and commercial bureau (2) license processing industrial and commercial bureau (3) engraved seal shop (4) tax u-stick digital center (5) bank basic account bank (6) **tax deduction agreement tax bureau and bank.

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.