1. There are 3 product quality supervision and inspection personnel with college degree or above in related medical specialty (among them, 1 is the person in charge of quality inspection);
2, three quality supervision and inspection personnel ID card and diploma copy, resume; (When the teacher of the Food and Drug Administration comes to the venue for inspection and interview, he/she needs to provide the original ID card and graduation certificate of relevant inspectors, and be present in person);
3. Company business license and medical device manufacturing enterprise license of other manufacturing enterprises selling medical devices;
Medical device registration certificates and medical device registration forms of other medical device manufacturers sold;
5. Sales authorization from other manufacturers of medical devices sold;
Medical device business license processing time:
About 3-4 months after the approval of the nuclear name.
The attached detailed process is as follows:
The first step is to check the industrial and commercial name.
Materials required:
1. Name Pre-approval Application
2. Identification certificate of the investor
3. Registered capital and contribution ratio
Processing time: 3-5 working days when the materials are complete and the names are not repeated.
Step 2 Application for License of Medical Device Business Enterprise
(a) the bid-winning notice
Materials required:
(1) Registration Form of Application Materials for Medical Device Business Enterprise License;
(2) Application Form for Shanghai Medical Device Business Enterprise License;
(3) A certificate of pre-approval of enterprise name or a copy of business license issued by the administrative department for industry and commerce;
(4) The ID card, certificate of education or professional title and a copy of the resume of the person in charge of quality management of the proposed enterprise;
(5) A copy of the ID card, education or professional title certificate of the quality management personnel of the enterprise to be established;
(six) the organization and functions of the enterprise to be established or the functions of full-time quality management personnel;
(7) A copy of the registered address of the proposed enterprise, 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 product quality management system document of the proposed enterprise (1 1 document) and the inventory of storage facilities and equipment;
(9) The business scope of the proposed enterprise shall be determined according to the management category and category code specified in the Catalogue of Medical Devices;
(10) Business license, product registration certificate (photocopy) and power of attorney of the entrusted seller of the products to be sold;
(10) electronic application materials; (needed for drug testing in Pudong);
(1 1) Other supporting documents that need to be provided.
Attachment: Specific requirements of application materials:
(1) The contents of the form must be complete and clear.
(2) At the same time, submit the electronic application form (on floppy disk) and A4 standard written documents (fax paper cannot report data).
(3) The application materials submitted by the applicant shall be complete, standardized and effective.
(2) Business License for Medical Devices
(1) After acceptance, the drug inspection department will conduct on-site inspection within 25 working days.
(2) Issue the Medical Device Business License within 10 working days from the date of making the decision to grant the license.
Processing time: 25 working days after the materials are complete and accepted.
Step three, industrial and commercial registration.
Materials required:
1. Certificate of the designated representative or entrusted agent of all shareholders (power of attorney) and a copy of the client's work permit or ID card;
2. Notice of pre-approval of enterprise name;
3, the shareholder's legal person qualification certificate or natural person identity certificate;
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. Articles of Association (sealed by all shareholders), and the articles of association of the group limited company (sealed by the member enterprises of the group) shall also be submitted;
8. Documents indicating the names and residences of the company's directors, supervisors and managers, and certificates of appointment, election or employment, including:
(1) letter of appointment (wholly state-owned);
(2) Letter of appointment (sealed by the appointing unit);
(3) The certificates of appointment of the chairman or executive director, director, supervisor and manager of the company;
(4) Copies of the identity cards of the company's directors, supervisors and managers;
9. A capital verification report issued by a legally qualified capital verification institution;
10. the company's domicile certificate, and the lease agreement (with a copy of the property right certificate) must be submitted for renting the house;
1 1. If the business scope of the company belongs to the items that must be submitted for examination and approval according to 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.
Processing time: 7 working days after the materials are complete.
Cost: It depends on the registered capital.
Step 4: Organization Code
Materials required:
1. Original and photocopy of business license (original and photocopy)
2. Identification certificate of the legal representative
Processing time: usually 5 working days; The expediting time is 1 working day.
Step 5: Tax registration
Required materials: same as industrial and commercial materials.
Additional requirements:
1, 4 copies of tax registration form
2. Organization code certificate
Two sets of the above materials are required.