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Individuals definitely can't handle it.
These need to be formally registered enterprises.
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This is not a no-no.
Specifically, you can take a look at the following ** regulations.
List of materials to be submitted for the first application:
1. Application.
2. Application form.
3. Qualification documents:
A copy of the business license of the enterprise legal person;
Copy of legal person's ID card and resume;
A copy of the capital verification certificate;
A copy of the domain name registration document;
4. Network and information security technical safeguard measures:
information security and confidentiality system;
information security audit system;
technical security measures;
user information security measures;
Letter of commitment for the security management of medical and health information content;
5. Introduction to the company's basic situation;
business development plan and related technical solutions for operational columns;
**Staff member**;
**Copies of resumes, responsibilities, identity certificates, and academic certificates of technical personnel;
**Resume, responsibilities, copies of identity certificates, copies of academic certificates, practice of medical personnel.
A copy of the doctor's qualification certificate and the doctor's practice certificate;
6. Description of the equipment of the network management center.
Catalogue of materials submitted for application review:
1. Application for review;
2. Report on the operation in the past two years;
3. Changes in columns.
4. **Column setting table;
5. The original notice of Internet information service review;
6. A copy of the business license of the enterprise legal person, a copy of the ID card of the legal person, and a copy of the capital verification certificate;
7. A letter of commitment signed by the company's legal representative to operate medical and health care in accordance with the law.
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As you said, it is generally filed and registered. In terms of pre-approval, you need to consult the local health department first, and they will generally ask you to bring any information. For example, business license, legal person ID card, acceptor's ID card, organization ** certificate, etc., these materials must be brought, and people should go to their hall to fill out the form.
The specific requirements of each place are different, and it is best to call ** consultation, and then it will be better. Generally, if you have done it before, and now you are getting a new one, it is best to ask before you operate, otherwise it has already been done, and the operation will be like the first operation, and you will start again.
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Under normal circumstances, if you know someone who knows you, you will either take money or handle it quickly, but at that time, if you follow the regular path, of course, it will be slower!
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The ** that has been pre-approved is a popular science that can't do anything**.
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Pre-approval is more complicated.
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What are you doing**? I can help you do it.
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According to Article 5 of the Measures for the Administration of Internet Information Services and the original Order No. 33 of the Ministry of Information Industry, pre-approval is required to engage in Internet information services such as news, publishing, education, medical care, medicine and medical devices, culture, radio, film and television programs, and online games. The following explanations are made for each pre-approval standard.
News Internet Information Service ICP License Preconditions:
Internet news information service refers to the publication of news information (current political news information, including reports and comments on political, economic, military, diplomatic and other social and public affairs, as well as reports and comments on social emergencies), the provision of current political electronic bulletin services and the sending of current political communication information to the public. Those engaged in Internet news information services shall apply for an Internet News Information Service License from the Information Office.
Preconditions for the ICP license for publishing and distributing Internet information services:
Internet publishing refers to the act of service providers selecting and processing works created by themselves or others, posting them on the Internet or sending them to users through the Internet for the public to browse, read, use, or disseminate. His works mainly include: officially published books, newspapers, periodicals, audio-visual products, electronic publications and other publications or works published on other **; Processed works of literature, art, natural sciences, social sciences, engineering technology, etc.
Educational Internet Information Service ICP License Preconditions:
Healthcare Internet Information Service ICP License Preconditions:
Internet health care information service refers to the service activities of providing health care information to Internet users through the establishment of medical and health institutions**, preventive health care knowledge**, or the establishment of preventive health care channels in the comprehensive **. Those engaged in Internet health care information services shall review and approve with the local health administrative department and the Chinese medicine management department, and obtain the "Internet Health Care Information Service Review and Consent".
Preconditions for ICP license for Internet information services for drugs and medical devices:
According to the Measures for the Administration of Internet Drug Information Services, Internet drug information services refer to the service activities of providing information on drugs (including medical devices) to Internet users through the Internet. If you intend to provide Internet drug information services, you should apply to the local provincial and municipal (food) drug regulatory departments and health departments, and obtain the qualification to provide Internet drug information services and obtain the "Internet Drug Information Service Qualification Certificate" after review and approval.
Preconditions for ICP License for Radio, Film and Television Programs Internet Information Services:
An audio-visual program consisting of a continuously moving image or a continuously audible sound that is filmed or recorded using cameras, camcorders, tape recorders, and other audio-visual recording equipment. Submit an application to the local administrative department for radio and television, and submit written materials, and if the conditions are met, a "Permit for Information Network Dissemination of Audiovisual Programs" shall be issued.
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The ICP license refers to the telecommunications operation that comprehensively provides Internet information services and value-added services to the majority of users. According to the Telecommunications Regulations of the People's Republic of China No. 291 and the Measures for the Administration of Internet Information Services (hereinafter referred to as the ICP Management Measures) No. 291 of the People's Republic of China, the state implements a license system for ICPs that provide Internet information services.
So, which companies need to apply for an ICP license?
4. Industries involved in pre-approval need to obtain the approval documents of the competent industry authority, and then apply for the ICP license.
What are the basic conditions for applying for an ICP license?
1. The registered capital of the company is at least 100W, and the subscription can be done;
2. Apply for social security for at least 3 employees under the name of the company;
3. The filing has been completed, and the content meets the approval requirements.
What documents do I need to prepare for an ICP license?
1. A copy of the business license;
2. Articles of Association;
3. ID card of legal person and shareholder;
4. Domain name certificate;
5. Server protocol and IDC ISP qualification of the server vendor;
6. Social security for three personnel.
An enterprise applying for an ICP license is not only a manifestation of compliance, but also a proof of comprehensive strength. It can bring better business income to the enterprise. For more information on ICP license processing, please contact Tianlei for consultation.
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For BAI Class II medical device business.
DU filing and registration address.
zhi has requirements:
1. Office surface.
The DAO area is not less than 40 square versions; (business building or storefront);
2. The warehouse area is not less than 15 square meters; (Our company can provide) (three types of refrigerated warehouses containing primary in vitro diagnostic reagents);
3. If there are three types of disposable products, the office address and warehouse area together shall not be less than 160 square meters;
If the warehousing is entrusted to a third-party logistics company, a logistics company with medical device licensing qualifications is required.
There are requirements for the filing personnel of the second class of medical device business:
1. One person with a bachelor's degree or above or an intermediate technical title in medical devices, medicine and pharmacy is responsible for quality.
2. 2 with high school degree or above, as a quality administrator;
Application materials required for medical device business record certificate:
1.Class II medical device business record form.
2.A copy of the business license and the ** certificate of the organization.
3.A copy of the identity certificate, academic background or professional title certificate of the legal representative, the person in charge of the enterprise, and the person in charge of quality.
4.Description of the organization and department settings.
5.Description of business scope and mode of operation;
6.Geographical location map of the business premises and warehouse address, floor plan, house property right certificate or a copy of the lease certificate issued by the housing lease;
7.Catalogue of operating facilities and equipment;
8.Catalogue of documents such as business quality management system and working procedures;
9.Proof of authorization of the person in charge.
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The requirements of each region are inconsistent, go to the municipal food and drug administration where your enterprise is located, or directly call the device department of the municipal food and drug administration to inquire.
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Medical devices must first go through the pre-approval before they can be recorded, now the pre-approval of the medical device industry is generally handled in the Food and Drug Administration, to fill in the State Food and Drug Administration unified preparation and issuance of the "Internet Drug Information Service Application Form", to the first sponsor (food) drug regulatory department to apply, and submit the following materials: 1A copy of the business license of the enterprise 2
Domain Name Registration.
3**Description of column setting (for applying for commercial Internet drug information services, ** need to provide a description of the charging column and charging method); 4.(food) drug regulatory department **browse all columns, content methods and operating instructions; 5.
** Relevant management system and implementation description for backing up and consulting historical release information; 6. Academic certificates of professional and technical personnel related to drugs and medical devices or copies of their professional and technical qualification certificates, and ID cards of the person in charge.
Photocopy and curriculum vitae; 7.Robust network and information security.
Safeguard measures, including security measures, information security and confidentiality management system, and user information security management system.
After the pre-approval is completed, a copy of the pre-approval document (pre-approval number), a copy of the business license of the enterprise, a copy of the legal person's ID card, a copy of the ID card of the person in charge, a copy of the person in charge, a domain name certificate, a verification form, an ICP information registration form, an information security agreement, and a letter of authorization.
Documents can be asked by your hole space dealer to send to you, these materials are stamped with the company's official seal.
After that, it will be sent to your space provider, and let the space access provider help you file the record, and the filing time is generally within 7-20 working days.
Hope it works for you.
It is difficult to approve the pre-approval, if you can't get the pre-approval, just follow the ordinary filing process, but you can't open the site during the filing period, and the name should not involve medical devices during the review period, and then change it back after the filing. You can also choose the extranet.
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The first record of medical device companies in Jiangsu Province is managed by the Jiangsu Provincial Food and Drug Administration, and there must be pre-approval. First of all, you have to go to the provincial bureau to apply for the "Internet Drug Information License".
In China, if you provide information on drugs (including medical devices) to Internet users through the Internet, you need to apply for the "Internet Drug Information Service License" The information certificate is divided into: business and non-business. According to their own needs, enterprises shall declare in accordance with the requirements of the "Measures for the Administration of Internet Drug Information Services" at the review authority of the local food and drug supervision and administration department.
Secondly, advertisements published in China through certain media and forms contain the name of the medical device, the scope of application of the product, the performance structure and composition, the mechanism of action, etc., it is a medical device advertisement. It is necessary to apply for the "Medical Device Advertising Approval Number", also known as the "Medical Device Advertising Review Form", at the local food and drug administration review authority.
If you want to sell medical devices online, you also need to do a "medical device network business record".
On March 1, 2018, the State Food and Drug Administration began to implement the Measures for the Supervision and Administration of Online Sales of Medical Devices, which stipulates that enterprises engaged in online sales of medical devices and providing online trading services of medical devices in China shall comply with these measures and conduct the "Medical Device Online Business Filing" at the review authority of the local food and drug supervision and administration department.
The predecessor of "Medical Device Network Business Record": formerly known as "Internet Drug Trading License" (divided into three categories: A, B, and C), it was changed to a filing system after the cancellation of approval in 2017, which was divided into "Medical Device Network Business Record" and "Drug Network Business Record".
There are two types of medical device network operation record: medical device production and operation enterprises and third-party platform providers of medical device online transaction services. Among them, "medical device production and operation enterprises" are divided into two categories: self-built ** and legal tripartite platforms.
For specific legal and regulatory requirements and approval procedures, you can go to the official website of the State Food and Drug Administration, or go to the official website of the Beijing Food and Drug Administration. Collapse.
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Just do an ordinary company ** filing on the line...
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