Registration conditions of Shanghai Medical Device Company:
The warehouse area is greater than 15_, and the office area is greater than 30_, which is planned according to the requirements of the Food and Drug Administration.
Registration process of Shanghai Medical Device Company:
The first step is to check the name of the enterprise.
Information required for verification of registered company name:
1. Title Pre-approval Request
2. Identity of investors
3. Registered capital and contribution ratio
Step 2: Materials required for medical device business enterprises to apply for license.
(a) the bid-winning notice
(1) Registration Form of License Application Materials for Medical Device Management Company;
(2) Application Form for License of Medical Device Trading Company;
(3) A certificate of pre-approval of the company name or a copy of the business license issued by the administrative department for industry and commerce;
(4) The ID card, copy of education or professional title and resume of the person in charge of quality management of the company to be established;
(5) A copy of the ID card, education or professional title of the quality management personnel of the company to be established;
(six) the organization and functions of the company to be established or the functions of full-time quality management personnel;
(7) A copy of the registered address of the company to be established, the geographical location map of the warehouse address, the floor plan (indicating the area), the property right certificate of the house or the lease agreement (with the property right certificate of the leased house attached);
(8) The document of the commodity quality management system of the company (1 1 document) and the catalogue of storage equipment and equipment;
(9) The business scope of the company to be established shall be determined according to the management category and category code title specified in the Classification Catalogue of Medical Devices;
(10) Business license, commodity registration certificate (photocopy) and power of attorney of the entrusted seller who intends to sell the goods;
(1 1) electronic declaration materials; (Pudong drug testing needs);
(12) Other supporting documents.
(2) License of Medical Device Management Company
Step three, industrial and commercial registration.
1. Confirmation letter (power of attorney) of all shareholders' designated representatives and entrusted agents, and a copy of the client's work permit or ID card;
2. Notice of pre-approval of company name;
3. Confirmation of shareholders' legal person status or natural person status;
4. An application for registration of a company 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 (sealed by all shareholders) and the Articles of Association of the Group (sealed by the member companies of the Group) shall be submitted by the Group Limited;
8. Documents indicating the names and residences of the company's directors, supervisors and managers, as well as the confirmation letter of dispatch, recommendation or appointment, including:
9. A capital verification report issued by a legally qualified capital verification institution;
10, the company's residence confirmed that the lease agreement (with a copy of the property right certificate) should be submitted for renting;
1 1. For projects that need to be approved according to laws and administrative regulations within the company's business scope, submit relevant consent documents;
12. If the establishment of a limited liability company is required to be approved by laws and regulations, the relevant consent documents shall be submitted;
13, a complete set of application forms issued by our bureau and other materials.