It is recommended that the company or their own registration, because you will have to be a business, drug supervision, tax to deal with
Since the money is not a problem, registration of a company is very easy
Registration process:
Application conditions: the warehouse area is greater than 15 square meters, the office area of more than 30 square meters
and in accordance with the requirements of the layout (agent guidance) >And in accordance with the requirements of the Drug Administration layout (guided by the agent)
The first step of industrial and commercial name search
Required materials:
1. Name pre-approval application
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 license application
(a) "Notice of Acceptance"
Required materials:
(1) "Medical Device Business License Application Materials Registration Form";
(2) "Medical Device Business License Application Form";
(3) Industrial and Commercial Administration issued by the Pre-approval of the enterprise name documents or a copy of the "business license";
(4) the proposed enterprise quality management responsible person's identity card, education or title certificate copies and personal resume;
(5) the proposed enterprise quality management personnel's identity card, education, or title certificates;
(6) the proposed enterprise organization and functions or full-time quality management personnel function;
(7) the proposed enterprise quality management personnel;
(8) the proposed enterprise quality management personnel;
(9) the proposed enterprise quality management personnel's identity card, education, or title certificates Management personnel functions;
(7) the proposed enterprise registered address, warehouse address geographic location map, floor plan (indicating the area), proof of property rights or lease agreement (with proof of property rights of the leased premises) copy;
(8) the proposed enterprise product quality management system documents (11 documents) and storage facilities, equipment directory;
(9) proposed Business scope of enterprises, in accordance with the provisions of the medical device classification directory of the management category, class code name to determine;
(10) the proposed sale of products commissioned by the seller's business license and product registration certificate (copy), authorization letter;
(10) electronic reporting materials; (Pudong Drug Inspection needs);
(11) other documents required to be provided to prove the case.
Attachment: specific requirements for the application materials:
(1) the content of the form can not be missing, 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
(B) "Medical Device Business License"
(1) approved acceptance, within 25 working days of the Pharmaceutical Inspection Department on-site inspection.
(2) from the date of the decision to grant permission within 10 working days from the date of issuance of "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 commissioning agent of the certificate (power of attorney) and the commissioned person's work permit or copy of ID card;
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 incorporation (all the shareholders) Seal), the group limited company must also submit the group articles of association (seal of the group members);
8, documents setting out the names and residences of the company's directors, supervisors and managers, as well as proof of appointment, election or employment, including:
(1) letter of appointment (wholly state-owned);
(2) letter of appointment (seal of the appointing organization);
(3) the chairman of the board of directors or executive directors, directors, supervisors, managers, proof of employment;
(4) the company's directors, supervisors, managers, a copy of ID cards;
9, with the legal qualifications of the capital verification agency issued by the capital verification report;
10, proof of the company's domicile, leased premises need to be submitted lease agreement (with a copy of property rights certificates);
11 If the company's business scope is one of the items that must be submitted for approval as stipulated by laws and administrative regulations, the approval documents of the relevant departments shall be submitted;
12. If the establishment of a limited liability company is one of the items that must be submitted for approval as stipulated by laws and administrative regulations, the approval documents of the relevant departments shall be submitted;
13. A full set of the registration forms and other materials issued by the Bureau.
Processing time: 5 working days after the materials are complete
Labor cost: depends on the registered capital
Step 4 Institutional Code
Required materials:
1, the original and the duplicate of the business license (original and photocopy)
2, the legal representative's identity certificate
Processing time: Normal is 5 working days; Expedited for 1 working day
Step 5 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 after the materials are complete
.