How to register a medical device company and how long does it take to register a medical device company? Shanghai consultants have compiled a set of materials for entrepreneurs who are ready to register a medical device company.
Medical device company registration process:
Application conditions: warehouse area is greater than 15_, office area is greater than 30_
And in accordance with the requirements of the Pharmaceutical Supervision Bureau of the layout (guided by the Mingxi operation)
First step of the industrial and commercial name checking
Required materials:
1. Application for pre-approval of the name
2. Investor identification
3. Registered capital, the proportion of capital contribution
Processing time: 3 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 Device Business License Application Form";
(3) business administration department issued by the enterprise name pre-approval documents or a copy of the "business license";
(4) the proposed enterprise quality management person in charge of the identity card, academic or professional title certificate copy and resume;
(4) the proposed enterprise quality management person's identity card, academic or professional title certificate and resume;
(5) the proposed enterprise quality management person's identity card, academic or professional title certificate copy and resume;
(6) the proposed enterprise quality management person's identity card, academic or professional title certificate and resume;
(5) the proposed enterprise quality management personnel identity card, education or title certificates;
(6) the proposed enterprise organization and functions or full-time quality management personnel functions;
(7) the proposed enterprise registered address, warehouse address of the geographic location of the map, floor plan (indicating the area), proof of ownership of the house or lease agreement (with the leasing of the property rights) copy;
(8) the proposed enterprise quality management personnel identity card, education or title certificates;
(9) the proposed enterprise quality management personnel identity card, education or title certificates;
(10) the proposed enterprise quality management personnel identity card, education or title certificates Proof) copies;
(8) proposed enterprise product quality management system documents (11 documents) and storage facilities, equipment directory;
(9) proposed business scope of the enterprise, in accordance with the provisions of the Medical Device Classification Directory of the management category, the class code name to determine;
(10) proposed sale of products to be sold commissioned by the seller's business license and product registration certificate ( Copies), authorization letter;
(10) electronic filing materials; (Pudong Pharmaceutical Inspection needs);
(11) other documents required to provide proof.
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 the 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 ID cards;
9, with the statutory qualifications of the capital verification agency issued by the capital verification report; (after the implementation of the new company law on March 1, 2014, the subscription system of enterprises this document is no longer required)
10, proof of the company's domicile, rental housing need to submit a lease agreement. Lease agreement (with a copy of the title certificate);
11, the company's scope of business, belonging to the laws and administrative regulations must be submitted for approval of the project, submit the approval documents of the relevant departments;
12, laws and administrative regulations must be submitted for approval of the establishment of limited liability companies, submit the approval documents of the relevant departments;
13, A full set of registration forms and other materials issued by the Bureau.
Processing time: 5 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 (the original, a photocopy)
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 of
Processing time: 15 working days with all the materials