1, three related medical graduates of college (including college) diploma product quality supervision and testing personnel (one of the quality testing responsible);
2, three quality supervision and testing personnel ID card and a copy of the certificate of graduation, work experience; (Food and Drug Administration teacher to come over to the site to verify the interviews);
3, the sale of medical devices each other manufacturer's company business license, and personally present);
3, the sales of medical devices each other manufacturer's company business license, the other manufacturer's company business license, and personally present). Need to provide the relevant inspectors of the original identity card and diploma, and in person);
3, the sale of medical devices to the manufacturer of the other company's business license, medical device manufacturer's license;
4, the sale of medical devices to the other manufacturer's medical device registration certificate, medical device registration form;
5, the sale of medical devices to each other Manufacturers of commissioned sales authorization;
Medical equipment business license processing time:
Nuclear name through the 3-4 months or so
Another detailed process is attached as follows:
The first step of the industrial and commercial name checking
Required materials:
1. name pre-approval application
2. investor identification
3. Registered capital, the proportion of capital contribution
Processing time: 3-5 working days if the materials are complete and the name is not duplicated
The second step of the medical device business enterprise license application
(a) "Acceptance of the notice"
Required materials:
(1) "Medical Device Business Enterprise License Application Materials Registration Form";
(2) "Shanghai Medical Devices Business License Application Form";
(3) business administration department issued by the enterprise name pre-approval of documents or "business license" copy;
(4) proposed enterprise quality management person in charge of the identity card, academic or professional title certificate copy and resume;
(5) ) proposed enterprise quality management personnel ID card, education or title certificate copies;
(6) proposed enterprise organization and functions or full-time quality management personnel functions;
(7) proposed enterprise registered address, warehouse address geographic location map, floor plan (indicating the area), proof of ownership of the house or lease agreement (with proof of ownership of the leased premises) copies;
(7) proposed enterprise registered address, warehouse address geographic location map, plan (indicating the area), proof of ownership of the house or lease agreement (with proof of ownership of the leased premises);
(8) proposed enterprise quality management personnel ID card, education or title certificates copies;
(8) the proposed enterprise product quality management system documents (11 documents) and storage facilities, equipment directory;
(9) the proposed business scope of the enterprise, in accordance with the medical device classification directory of the management category, the class code name to determine;
(10) the proposed sale of products to be entrusted to the seller's business license and product registration certificate (copy), authorization letter;
(11) the proposed enterprise product quality management system documents (11 documents) and storage facilities, equipment directory;
(12) the proposed enterprise business scope of the medical device classification directory, the management category, class code name to determine;
(13) the proposed enterprise product quality control system documents (11 documents) and the storage facility, equipment directory;< /p>
(10) electronic filing materials; (Pudong Pharmaceutical Inspection needs);
(11) other supporting documents to be provided.
Attachment: specific requirements for the application materials:
(1) the contents of the form can not be missing items, clear handwriting
(2) at the same time, the electronic copy of the application form (placed on a floppy disk) and A4 specification of the written information (fax paper can not be reported as information) each one
(3) applicants to submit the application materials should be complete, standardized, effective
(ii) "Medical Device Business License"
(1) approved acceptance, 25 working days after the drug inspection department on-site inspection.
(2) 10 working days from the date of the decision to grant permission to issue the "Medical Device Business Enterprise License".
Processing time: 25 working days after acceptance of complete materials
The third step of industrial and commercial registration
Required materials:
1, all shareholders to designate a representative or *** with the proxy's certificate (power of attorney) and a copy of the work permit or identity card of the person to whom it is delegated;
2, notice of pre-approval of the name of the enterprise;
3, the shareholders of the certificate of legal personality or natural person identification;
4, the company chairman or executive director signed the application for registration of the establishment of an enterprise legal person;
5, the resolution of the shareholders' meeting (shareholders' seal, signature of the natural person shareholders);
6, the resolution of the board of directors (signed by all the directors);
7, the articles of association (all shareholders) Seal), the group limited company also need to submit the group articles of association (group member enterprises seal);
8, documents setting out the names and residences of the company's directors, supervisors, managers, and proof of appointment, election or employment, which include:
(1) letter of appointment (wholly state-owned);
(2) letter of appointment (seal of the appointing organization);
(3) the chairman of the company or executive director, director, supervisor, manager of the certificate;
(4) company directors, supervisors, managers, a copy of identity cards;
9, with the legal qualifications of the capital verification agency issued a capital verification report;
10, the company's residence certificate, lease housing need to be submitted to the lease agreement (accompanied by a copy of the certificate of property rights);
11 In the business scope of the company, belonging to the laws and administrative regulations must be submitted to the approval of the project, submit the approval documents of the relevant departments;
12, laws and administrative regulations provide for the establishment of a limited liability company must be submitted to the approval, submit the approval documents of the relevant departments;
13, a full set of registration forms and other materials issued by the Bureau.
Processing time: 7 working days after the materials are complete
Working fee: depending on the registered capital
The fourth step of the institutional code
Required materials:
1, the original and the duplicate copy of the business license (original and photocopies)
2, the legal representative of the identity card
Processing time: Normal 5 working days; expedited to 1 working day
Processing time: Normal 5 working days. Expedited for 1 working day
The fifth step of tax registration
Required materials: the same as the industrial and commercial materials
Additional requirements:
1, 4 copies of the tax registration form
2, the institutional code certificate
Above the materials need to be 2 sets