What are the requirements for a registered medical device company?

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.

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.

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 above are the conditions for the registration of medical device companies, today's Zhishuo sharing is here, if you still have any questions about the conditions of registered medical device companies, you are welcome to contact Shanghai Zhishuo Enterprise Management Group at any time.

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.

The following conditions are required for medical device company registration:

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 nature, and residential buildings cannot be used as registered addresses;

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 stakeholders, the people's court may rule to approve it on the basis of the application of the liquidation group. After the liquidation team repays the 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.

Does medical device company registration require pre-approval? , welcome to follow, like, next wonderful content recommendation, business handling, please private message or**, 1, medical device sales, production (except for Class I medical devices) (District Food and Drug Administration), drugs (District Food and Drug Administration, Health Bureau); 2. Retail and printing of books, newspapers and periodicals, newspapers and periodicals (District Cultural Management Institute, Municipal Press and Publication Bureau); 3. Sales of audio-visual products (District Cultural Management Office); 4. Liquor wholesale (District Liquor Monopoly Bureau); 5. Food (District Health Bureau); 6. Establishment of medical structure (District Bureau of Culture and Welfare); 7. Tobacco sales (Tobacco Monopoly Bureau); 8. Catering (District Environmental Protection Bureau, District Culture and Health Bureau, District Fire Department); 9. Hotels and guest rooms (District Public Security Bureau, District Fire Department, District Health Bureau); 10. Production and processing of plastic products and water-based coatings (District Environmental Protection Bureau); 11. Road transport, water and land transport (Transportation Bureau); 12. Automobile and motorcycle maintenance (Maintenance Management Office of the Municipal Transportation Commission); 13. Talent intermediary (District Personnel Bureau); 14. Labor service (District Labor Bureau); 15. Scrap metal acquisition (District Public Security Bureau, District Environmental Protection Bureau); 16. Refined oil management and storage (Municipal Economic Commission, Public Security Bureau); 17. Processing, sales, gold and silver (Financial Department of the Municipal People's Bank); 18. Cultural relics management (cultural relics management committee); 19. Commercial dance halls (Municipal Cultural Bureau, Cultural and Biological Bureau, Public Security Bureau, Fire Department); 20. Chinese painting and calligraphy (Municipal Bureau of Culture); 21. Cafes and taverns (health department, public security cloth door, Municipal Liquor Monopoly Bureau); 22. Customs declaration business (General Administration of Customs); 23. Cement production (Municipal Construction Committee); 24. Air transport sales ** business (Civil Aviation Central and South Administration); 25. Cosmetics production (Municipal Health Bureau); 26. Project contracting (Municipal Construction Committee).

1. The warehouse area is more than 15 square meters, 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; 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 acceptance notice and the medical device business enterprise license;

4. Register with the Industrial and Commercial Bureau.

The Extended Information has the materials required for the Notice of Acceptance:

1. After receiving the registration application, the Trademark Office will first conduct a formal examination;

2. If it is found 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. Proof of the designated representative or co-entrusting person of all shareholders and a 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;

6. Resolution of the board of directors;

7. Articles of association, the group **** also needs to submit the group articles of association and the seal of the group member enterprises;

8. Documents indicating the names and addresses of the company's directors, supervisors and managers, as well as certificates related to appointment, election or employment, including letters of appointment, letters of appointment, certificates of appointment of the chairman of the board of directors or executive directors, directors, supervisors and managers of the company, and copies of ID cards of directors, supervisors and managers of the company;

9. Capital verification report issued by a legally qualified capital verification agency;

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

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

Laws and Regulations

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 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.

The following conditions are required for medical device company registration:

1. Have a quality management organization or full-time quality management personnel suitable for the business scope and business scale. Quality management personnel shall have relevant professional qualifications or professional titles recognized by the state; And there are relatively independent business premises that are suitable;

2. Have a sound product quality management system;

3. The office area is more than 90 square meters.

Legal basis

Article 9 of the Regulations on the Supervision and Administration of Medical Devices.

The following materials shall be submitted for the filing of Class I medical device products and the application for registration of Class II and Class III medical device products:

1) Product risk analysis data;

2) Product technical requirements;

3) Product inspection report;

4) Clinical evaluation data;

5) Product manuals and label samples;

6) Quality management system documents related to product development and production;

7) Other materials required to prove the safety and effectiveness of the product. The applicant for medical device registration and the filing person shall be responsible for the authenticity of the submitted materials.

Article 29 of the Regulations on the Supervision and Administration of Medical Devices.

To engage in medical device business activities, there shall be business premises and storage conditions suitable for the scale and scope of business, as well as quality management systems and quality management institutions or personnel suitable for the medical devices operated.

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.