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

(two) the person in charge of the quality inspection institution shall have a college degree or above or an intermediate title or above;

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

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

(5) Having a production and storage place and environment suitable for the products and scale of production;

(6) Having corresponding production equipment;

(7) An enterprise shall collect and keep the laws, regulations, rules and relevant technical standards related to its production and operation.

Information required to register a medical device company:

1. Certificates of all shareholders' representatives or * * * entrusted agents (power of attorney) and a copy of the client's work permit or ID card;

2, the enterprise name pre-approval notice

3. The legal person qualification certificate or the identity certificate of a natural person of the shareholder.

4. An application for registration of the establishment of an enterprise as a legal person signed by the company's chairman or executive director.

5. Resolution of shareholders' meeting (seal of shareholders and signature of natural person shareholders);

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

7. The articles of association of the company (sealed by all shareholders) and the articles of association of the group limited company are the articles of association of the group (sealed by the member enterprises of the group);

8. Documents indicating the names and residences of the company's directors, supervisors and managers, and certificates of entrustment, election or employment. Includes the following contents:

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

2) Power of Attorney (seal of entrusting organ);

(3) The certificates of the chairman of the board of directors or the executive directors, directors, supervisors and managers of the company.

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

9. A capital verification report issued by a legally qualified capital verification institution (after the implementation of the new company law on Mar. 65438 and Mar. 20, 2004, the appointed enterprise no longer needs this document).

10, the address of the unit proves that the rental house must be equipped with a lease agreement (copy of the tickets);

1 1. If the business scope of the company needs the approval of laws and administrative regulations, the approval documents of relevant departments shall be submitted;

12. If the establishment of a limited liability company is subject to approval according to laws and administrative regulations, the approval documents of relevant departments shall be submitted;

13, a full set of application forms and other materials issued by our bureau.

The process of registering a medical device company:

1. The founder needs to go to the administrative department for industry and commerce to handle the company name pre-approval notice.

2. Registered medical device enterprises need to submit online application materials to the website of local food and drug administration.

3. After the founder's online materials are approved, the local drug supervision department will make an appointment to check the business premises.

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

5. The promoters open capital verification accounts, the shareholders contribute capital, and the capital verification reports related to accounting affairs.

6. The founder applies for a business license.

7. Go to the carving company and get ready for business.

8. Go to the relevant departments for the organization code certificate.

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

The above are the conditions for registering a medical device company, and the sharing of Zhi Shuo Bian Xiao is here today. If you have any questions about the registration conditions of medical device companies, please feel free to contact Shanghai Zhishuo Enterprise Management Group Co., Ltd..