What information is needed to apply for a medical device company

Medical equipment, that is, immediately or indirectly used for the body's instruments, machinery, equipment, diagnostic reagents and corrective substances, raw materials and other similar or corresponding objects, the actual subdivision of the general low-value medical consumables, mainly under the medical equipment specialized in the treatment of raw materials, such as cardiovascular interventions, peripheral vascular interventions, external fixation stents, other visceral organs intervention to replace the other medical materials; low value medical consumables are generally disposable medical equipment sanitary materials; there are also medical devices and IVDs, and so many medical equipment companies are engaged in the business process of the development of the industry. Low-value medical consumables are generally disposable medical equipment and sanitary materials; there are also medical devices and IVDs, etc., so many medical equipment companies are engaged in business processes related to industrial development. That _ apply for registration of medical equipment company must what information? The first thing you need to do is to get a good deal of money to pay for it. The following is a brief introduction.

First, apply for registration of medical equipment companies must be what information

1, company name: in the enterprise name to meet the standard and must be more than the preparation of a number of company names, in case of unsuccessful enterprise name must be re-approved;

2, the company's registered address: must be real detailed address must be given to the housing information material, the landlord information content and rental information content; industrial parks detailed address applications Registered area agent to give on it;

3, the company's registered capital from March 2004 to register the company from the contribution system changed to the implementation of the subscription system, _ there are assets limited to the provisions;

4, the company's scope of business must be based on the sequence of business operations to carry out the operation of business processes to fill out a good;

5, the project investor, the executive director, the company's supervisors and other high-level residential staff ID card The content of the document and contact phone information.

Second, registered sales of medical equipment company operating steps

1, the company name approval: in the submission of the name and must be prepared in advance of the investor's identity information, the company's scope of business, the company's registered address information content and other materials;

2, the submission of industrial and commercial registration materials: prepared in advance of the above materials to upload the content of the information on the Internet to apply for the application, the application according to the later must be held in local Administration of Industry and Commerce to carry out the approval;

3, received the business license: after the audit must be received after the industrial and commercial business license;

4, the company must apply for a post-camera license certificate

5, the record engraved seals, the company's tax changes, such as the bank account agent company.

Third, apply for marketing medical equipment companies need what qualification certificates

The basic medical equipment see more than three types, and different types of regulations are not the same.

A class of medical devices is a low level of risk, the implementation of routine management can ensure its safety and efficiency of medical equipment, such as surgical blades, surgical treatment scissors, manual hospital beds, medical ice packs, cooling paste, etc., its equipment and manufacturing activities by the municipal drug supervision and management unit of the city to implement the report management method. Production and operation of all the relaxation, neither the need to approve and no need to report, only need to obtain the business license issued by the Industrial and Commercial Bureau can be.

Class II medical devices are mild to moderate risk, must be enterprise management methods to ensure the safety and efficiency of medical equipment, such as band-aids, condoms, thermometers, blood pressure measuring device, medical oxygen concentrators, electronic cigarette atomizers, etc., its equipment and manufacturing activities by the provincial drug supervision and management units to implement the license management methods, each sent to the "medical device" and "medical device production". Registration Certificate" and "Medical Device Production License". Production and operation by the municipal drug supervision and management units to implement the report management method;

Class III medical devices are with a higher risk, must be used in particular countermeasures to ensure the safety and efficiency of medical equipment, such as commonly used syringes, injecting needles, intravenous needles, cardiovascular stents, anesthesia, CT, magnetic **** vibration, etc., the equipment and business activities of the subject of the respective free state General Administration, provincial and ministerial drug supervision and management units and municipal drug supervision and management units to implement the license management method, each sent to the "Medical Device Registration Certificate", "Medical Device Manufacturing License", "Medical Device Business License".