Excuse me, how to apply for the second-class medical device business license of Taobao? First, it is not necessary to apply for a business license to operate the second class medical devices, but only to apply for a record certificate.
Second, the specific process:
(1) First, apply for a business license in the Industrial and Commercial Bureau and register as an enterprise, which can be a legal person enterprise, an unincorporated enterprise, a sole proprietorship enterprise, a partnership enterprise, etc. Individual industrial and commercial households may not apply for filing vouchers.
(2), and then to the quality supervision bureau for organization code certificate.
(3) Finally, register an account with an organization code on the website of the State Food and Drug Administration of the United States, and make an online declaration.
(4) Electronic materials to be submitted for online medical device filing, in which * is required.
1.* Copy of business license and organization code certificate
2 * A copy of the identity certificate, education or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of quality.
3.* Description of organization and department settings
4 * Description of business scope and mode of operation
5 * A copy of the geographical location map, floor plan, house title certificate document or lease agreement (with house title certificate document attached) of the business premises and warehouse address.
6.* Catalogue of operating facilities and equipment
7.* Manage the directory of documents such as quality management system and working procedures.
8. Basic introduction and functional description of computer information management system
9.* Agent's authorization certificate
10.* Scanned application form signed and stamped with official seal.
Three, the second class of medical devices for the record, the examination and approval department for the municipal food and drug administration. After the online declaration is accepted, the enterprise provides paper materials to the government affairs hall as required. After the on-site acceptance is qualified, it can operate with a filing certificate.
What documents do people who apply for the second-class medical device business license need? The identity certificate, educational background or professional title of the legal representative, the person in charge of the enterprise and the person in charge of quality are photocopies.
Simply put, it is a copy of the ID card of the legal person, the person in charge and the person in charge of quality; Copy of college diploma or intermediate title certificate of quality supervisor.
If these three people are one person, you only need to provide a copy of this person's ID card, academic certificate or professional title certificate.
There are three types of medical device business licenses. If you want to increase the business scope-medical device leasing, which type of license do you need to apply for? Where is the examination and approval department? If you have three types of medical device business licenses, you don't need to apply for one more lease. You can go to the local industrial and commercial bureau to change your business license!
Does the Food and Drug Administration still review the business license of medical devices? Shanghai professional registered medical device company and applied for approval of medical device business license. Other companies can also register and provide addresses. Please ask in detail. The user name is my mobile phone. The US Food and Drug Administration conducts random inspection of medical device enterprises, and will conduct annual inspection when it is drawn. Annual inspection is needed when it expires.
Kneel down and ask for my medical device business license, fees and handling conditions. If you only deal in one kind of products, there is no mandatory requirement for business license in the regulations. But in many cases, consumers or hospitals need to see your business license before they can buy or bid. Processing files is very simple, and the program is relatively simple. You can refer to the website of the Municipal Bureau.
Our company is a financial leasing company. Do I have to have a warehouse to apply for the second and third medical device business licenses? To apply for the business record certificate of Class II medical devices and the business license of Class III medical devices, it is necessary to have a product warehouse that meets the business scope and to conduct on-site inspection and verification.
Where does the user name and password of the online form for downloading the third-class medical device business license come from? In which province did you download the form from the Food and Drug Administration? Whether the business license needs to be declared online depends on the requirements of each city. Generally, you should register your account online (or declare your account and password online at the local municipal bureau), then declare, enter your account name and log in secretly.
The medical device business license has not been processed. Can I issue an invoice? Did you get the business license? Most importantly, your tax and organization code cannot be invoiced until it is waiting. It has little to do with the medical device business license. How dare you sell products before the medical device business license has come down? This is an illegal act.
Does a pharmaceutical company need a medical device business license to distribute moxibustion in China? Hello, China moxibustion is one of the most important treatments in ancient China. It is a method of external treatment for internal diseases by burning acupuncture points with drugs, transforming human energy into biological energy, activating human meridians and regulating physiological balance, and achieving the purpose of treating diseases.
Han Shu Literature and Art Annals integrates three ancient methods of treating diseases: moxibustion, ironing, acupuncture and decocting. Moxibustion can be widely used to treat internal and external diseases, gynecological diseases, pediatric diseases, facial features and other diseases, and can be used to treat various acute and chronic diseases, common diseases and difficult diseases. Clinically, "a blow on the skin will stop the pain;" Moxibustion is done one box at a time, except for the sink. This product adheres to the traditional therapeutic principles of moxibustion, strengthening the body resistance and eliminating pathogens, and treats both the symptoms and root causes, and is made by modern technology. Its characteristic is moxibustion.
Therapy and drug therapy have dual effects, and the effect is more obvious.
From this perspective, what you need to apply for is not a medical device business license. You need to issue a pharmaceutical (Chinese herbal medicine) business certificate to the provincial administrative department of traditional Chinese medicine and the pharmaceutical supervisory and administrative department (the former health administrative department) to issue a pharmaceutical business license.