Agent medical device sales license registration

Medical device license for the premise is to register a new company, the required materials and processes refer to the registration of ordinary new companies.

Medical device license process:

1, check the name

2, for the business license

3, for the medical device license

4, change the scope of business (add the second class, the third class of medical devices business scope)

Medical device license for the required materials

1, three related medical graduates of college (including college) Diploma product quality supervision and testing personnel (one of which is the person in charge of quality testing);

2, three quality supervision and testing personnel ID card and a copy of the diploma, work resume; (Food and Drug Administration teacher to come to the site to verify the interviews need to provide the relevant testing personnel ID card and the original diploma, and I was present);

3, the sale of medical equipment each other manufacturer's company Business license, medical device manufacturer's license;

4, the sale of medical devices to the manufacturer of medical equipment registration certificate, medical device registration form;

5, the sale of medical devices to the manufacturer of the commissioned sales of authorization;

Attached detailed process is 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: complete materials, the name does not repeat the case, 3-5 working days

The second step of the medical device business license application

(a) "Acceptance of the notice"

(1) "Medical Device Business License Application Materials Registration Form";

(2) "Medical Device Business License Application Materials Registration Form";

(2) "Medical Device Business License Application";

(3) industrial and commercial administration issued by the business name pre-approval documents or "business license" copy;

(4) the proposed enterprise quality management responsible person's identity card, education or title certificate copy and biography;

(5) proposed enterprise quality management personnel's identity card, education or title certificate Copies;

(6) proposed business organization and functions or full-time quality management personnel functions;

(7) proposed business registered address, warehouse address geographic location map, floor plan (indicating the area), proof of ownership of the house or a copy of the lease agreement (with proof of ownership of the leased premises);

(8) proposed business product quality management system documents (11 documents) and storage Facilities, equipment directory;

(9) the proposed business scope of enterprises, in accordance with 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;

(10) electronic reporting materials; (Pudong Pharmaceutical Inspection need to be);

(11) other documents required to provide The following is a list of all the documents that are required to be provided.

Attachment: application materials specific requirements:

(1) form content can not be missing items, clear handwriting

(2) while reporting the application form electronic text (on a diskette) and a4 specifications of the written information (fax paper can not be reported as information) each

(3) the applicant to submit the application materials should be complete, standardized, effective

(B) "Medical Device Business Enterprise License License"

(1) approved acceptance, 25 working days after the drug inspection department on-site inspection.

(2) from the date of the decision to grant permission within 10 working days of the issuance of "medical device business license.

Processing time: materials complete acceptance, 25 working days

The third step of industrial and commercial registration

1, all shareholders designated representative or *** with the proxy certificate (power of attorney) and a copy of the work permit or ID card of the delegate;

2, pre-approval of the enterprise name notification;

3, the shareholders of the certificate of legal personality or the identity of the natural person;

4, the chairman of the board or executive director of the company;

5, the company has been the first time in the past three years. p> 4, the chairman of the board or executive director of the company 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 board of directors' resolution (signed by all the directors);

7, the articles of association (all shareholders' seal), the group limited company is also required to submit the group's articles of association (the group members of the enterprise seal);

8, the names of directors, supervisors and managers of the company Directors, supervisors, managers of the name and residence of the document and the appointment, election or employment of proof, including:

(1) letter of appointment (wholly state-owned);

(2) letter of appointment (appointed unit seal);

(3) the company's chairman or executive director, directors, supervisors, managers, proof of employment;

(4) the company's directors, supervisors, managers, copies of ID cards.

9, with the legal qualifications of the capital verification agency issued by the capital verification report;

10, the company's residence certificate, rental housing should be submitted to the lease agreement (with a copy of the property rights certificate);

11, the company's business scope, belonging to the laws and administrative regulations must be submitted for approval of the project, submit the approval documents of the relevant departments;

12, the establishment of laws and administrative regulations must be subject to approval of the Limited liability company must be submitted for approval, submit the approval documents of the relevant departments;

Processing time: materials complete, 7 working days

Pacific Group, focusing on medical qualifications for 13 years, will do our best to provide the production of medical devices (medical device products for the record, the medical device registration certificate, the medical device production license,), business (medical device business record certificate, the medical device business license, network sales record certificate, the medical device business license, the medical device business license, the medical device business license, the medical device business license, the medical device business license, the network sales record certificate. The company also has a wide range of medical devices, such as medical equipment products, medical device registration certificates, medical device production licenses, medical device business licenses, medical device business licenses, network sales record certificates), changes, renewal of licenses and other services.

Pacific enterprises have a wide range of social contacts, complete, scientific quality management system, the whole transparent consumption, no hidden charges, save money, time and worry about the operation of the way to help the enterprise safe and fast for all kinds of medical equipment qualification. Pacific has accumulated a large number of successful cases of Hong Kong and Guangdong customers, won the unanimous praise of old customers, and enjoys a good reputation in the industry! Pacific is dedicated to providing one-stop services for enterprises, adhere to the "passionate service, reputation first" purpose, we promise: abide by professional ethics, keep customer confidentiality. To provide customers with high-quality, enthusiastic and thoughtful service