What are the procedures for registering a medical device company

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. The registered capital shall not be less than RMB 2 million;

2. There are fixed business premises and facilities suitable for carrying out business, the company's registered address is different from the requirements of general individual industrial and commercial households, the company's registered address must be office in nature, and residential buildings cannot be used as a registered address;

3. Have a labor dispatch management system that complies with laws and administrative regulations;

4. Other conditions stipulated by laws and administrative regulations.

Legal basisArticle 16 of the Company Law of the People's Republic of China.

Where the people's court organizes liquidation, the liquidation group shall complete the liquidation within six months from the date of its establishment.

If the liquidation cannot be completed within six months due to special circumstances, the liquidation team shall apply to the people's court for an extension.

Article 17. If the liquidation team appointed by the people's court discovers that the company's assets are insufficient to pay off debts when it liquidates the company's property and compiles the balance sheet and property list, it may negotiate with the creditors to formulate a relevant debt repayment plan.

If the debt repayment plan is confirmed by all creditors and does not harm the interests of other interested parties, the people's court may rule to approve it on the basis of the application of the liquidation group. After the liquidation group repays its debts in accordance with the repayment plan, it shall apply to the people's court for a ruling to terminate the liquidation procedure.

If the creditor refuses to confirm the debt repayment plan or the people's court does not approve it, the liquidation group shall apply to the people's court for a declaration of bankruptcy in accordance with law.

How to register a company.

1. Take the name of the company and go through the name approval procedures at the local industrial and commercial bureau;

2. Open a capital verification account at the bank to verify the registered capital;

3. The capital verification report shall be issued by the capital verification unit;

4. Apply for the "Labor Dispatch License";

5. Prepare the resolution of the shareholders' meeting and draft the articles of association;

6. Apply for a business license.

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. Name verification: Go to the Industrial and Commercial Bureau to get an "Application Form for Pre-approval of Enterprise (Trade Name) Name", fill in the name of the company you are going to take, and search whether there is a duplicate name on the Internet (intranet of the Industrial and Commercial Bureau) by the Industrial and Commercial Bureau.

2. Renting a house: Go to a special office building to 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 articles of association 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 (promoters), 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 name verification, the articles of association, the rent contract, and the copy of the real estate certificate. It takes about 15 working days to collect the license.

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 ID card. 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, you should apply for invoices from the local tax.

Documents are required for medical device company registration.

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. The front was late.

How many departments do you have to run for the registration of a medical device company?

1) Check the name of the Jutan Industrial and Commercial Bureau.

2) License for Industry and Commerce Bureau.

3) Engraving and engraving shop.

4) Taxes. 5) Basic bank account.

6) **Tax Deduction Agreements: Tax Offices and Banks.

Measures for the Administration of Medical Device Registration》 Article 9 The applicant for medical device registration and the filing person shall establish a quality management system related to product development and production, and maintain effective operation. When applying for registration of domestic medical devices approved by Yinli in accordance with the special approval procedures for innovative medical devices, if the samples are entrusted to other enterprises, they shall be entrusted to the medical device manufacturers with the corresponding production scope; When applying for registration of domestic medical devices that are not approved in accordance with the special approval procedures for innovative medical devices, the samples shall not be entrusted to other enterprises for production.

Process for registering a medical device company:

1.The founders need to go to the business administration to process the pre-approval notice of the company name.

4.The founders submit a written application and once approved, a medical device business license will be issued.

5.The founder opens a capital verification account, the shareholders make capital contributions, and the accounting firm reports on the capital verification.

6.The founder applies for a business license.

7.Go to the engraving company needed and prepare for business.

8.Go to the relevant department to process the organization** certificate.

9.Personnel of registered medical device companies apply for tax registration certificates from relevant departments.

Information required for registration of medical device companies:

1. The certificate (power of attorney) of all shareholder representatives or the person who jointly refers to the entrusting person and a copy of the work card or ID card of the entrusted person;

2. Notice of pre-approval of enterprise name.

3. Certificate of legal personality or natural identity of the shareholder.

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 general meeting of shareholders (sealed by shareholders and signed by natural person shareholders);

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

7. The articles of association of the company (stamped by all shareholders) and the articles of association of the group (stamped by the members of the group);

1) Letter of appointment; Wholly state-owned);

2) Power of attorney (stamped by the entrusting authority);

3) Proof of appointment of the chairman of the 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. The capital verification report issued by the legally qualified capital verification agency (after the implementation of the new company law on March 1, 2014, the appointment system enterprises no longer need this document).

10. Proof of address of the unit, and the rental house must be accompanied by a lease agreement (a copy of the ticket);

11. In the company's business scope, the projects that must be approved by laws and administrative regulations shall be submitted to the relevant departments for approval;

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

13. A full set of registration forms and other information issued by the Bureau.

The conditions for registering a medical device company 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.

If you still have any questions about the procedures for registering a medical device company, you are welcome to contact Shanghai Zhishuo Enterprise Management Group at any time.

With the raging epidemic, the global demand for medical equipment continues to rise, all for entrepreneurs who need to buy and sell medical devices, it is imminent to apply for a medical device business license, and it is more difficult to register a medical device company than an ordinary company.

Conditions for the registration of medical device companies.

1.The company needs to have a quality management organization or quality management personnel suitable for the business scope and business scale, and the quality management personnel shall have relevant professional qualifications or professional titles recognized by the state. It should be noted that in addition to having relevant professional qualifications or professional titles, the quality person in charge of operating three types of medical device enterprises should also have more than 3 years of experience in medical device operation and quality management;

2.It has a business and storage place that is suitable for the business scope and business scale. For example, if you are engaged in Class III or Class II in vitro diagnostic reagents, the usable area of the business premises shall not be less than 100 square meters, the usable area of the warehouse shall not be less than 60 square meters, and the volume of cold storage shall not be less than 20 cubic meters, etc. (different policy requirements are different in different regions).

All companies that entrust other medical device business enterprises to store may also not set up warehouses;

3.There is a quality management system suitable for the medical devices operated;

4.Have the ability of professional guidance, technical training and after-sales service suitable for the medical devices operated, or agree to provide technical support by relevant institutions. In addition to these, enterprises engaged in the operation of third-class medical devices should also have a computer software management system that meets the requirements of medical device management quality management to ensure that the products can be traced, which are the basic conditions.

5. Interview the person in charge of the company and the quality management personnel, and the Food and Drug Administration Tongshifang should have a basic understanding of the enterprise.

Medical device company registration process.

Step 1: The founder needs to go to the business administration to process the pre-approval notice of the company name.

Process 4: The founders submit written application materials, and once approved, a medical device business license will be issued.

Process 5: The founder opens a capital verification account, the shareholder contributes capital, and the accounting firm reports the relevant capital verification report.

Step 6: The founder applies for a business license.

Step 7: Go and engrave the company's required seal and prepare for business.

Documents required for the registration of medical device companies.

1. The name and business scope of the enterprise, the registered capital and the proportion of shareholders' capital contribution, and the identity certificate of shareholders;

2. Medical device product registration certificate, business license, permit and authorization letter of the first merchant;

3. Quality management documents, etc.;

Certificates, identification and curriculum vitae of one or more medical professionals or related professionals;

5. Proof of office space and warehouse that meet the requirements of medical device operation;

6. Articles of association, resolutions of shareholders' meetings, etc.;

7. ID card and employment certificate of financial personnel;

8. Other relevant materials;

The time for handling the "Medical Device Business Enterprise License" and company registration is within 15 working days.