Filing requirements of Ct machine

How to apply for medical device registration certificate?

1.

Apply online. The applicant submits the pre-trial application online, and the enterprise should also submit the pre-acceptance number when submitting the paper application materials;

2.

Window acceptance. Enterprises submit paper application materials to the window, and the acceptance personnel check the application materials and make an acceptance decision on the spot;

3.

On-site review. After acceptance, the examiner will review the materials and make a review decision on the spot;

4.

Get the result. The applicant receives the Record Voucher for the Production of Class I Medical Devices or the Decision of Not Passing on the spot at the window.

What is the procedure for ct to do EIA?

I. Project establishment

1. Preparation of project documents

2. Take the project book to the opening session of the district where you are located to apply for project filing (ask the materials needed for filing before going).

Second, the EIA

1. After the filing is completed, go to the local environmental protection bureau to handle the EIA with the filing materials. If only the EIA report form is needed, the enterprise can fill it out independently, and basically no cost will be incurred; If it is necessary to prepare an EIA report, the Environmental Protection Bureau will recommend several qualified assessment agencies to help complete the preparation of the report and all the work in the EIA, and the selection of EIA agencies will incur costs.

2. Choose the EIA agency to sign the contract, and the cost generally depends on the investment amount.

3. The EIA agency will visit the site, and the enterprise will provide all the information and details needed in the EIA (production process, details of various raw materials used and annual consumption, storage methods, waste treatment methods, raw material components, etc.). ). In addition, whether there is noise and how to solve it; Whether there is industrial wastewater and how to treat it; Whether there are harmful gases in the waste gas and how to deal with them; Whether there is waste residue and how to deal with it; How to deal with all kinds of industrial waste, etc. )。

Description of filing and licensing of Class I, Class II and Class III devices?

Class I: No medical device license is required.

The first type of medical equipment is low risk and can be guaranteed to be safe and effective through routine management, such as scalpels, surgical scissors, manual sickbeds, medical ice packs, cooling stickers and so on. Its products and production activities are managed by the municipal food and drug supervision department with districts. All business activities are liberalized without permission or filing, and only the business license issued by the industrial and commercial department is required.

Category II: The US Food and Drug Administration is responsible for the management of medical devices.

The second kind of medical devices are medical devices with moderate risk and need strict control and management to ensure their safety and effectiveness, such as band-AIDS, condoms, thermometers, sphygmomanometers, oxygen generators, atomizers and so on. Its products and production activities are managed by the provincial food and drug supervision department, and the Medical Device Registration Certificate and the Medical Device Production License are issued respectively. Business activities shall be filed by the municipal food and drug supervision department with districts.

Requirements for Class II medical devices

1, with a storage area of 45 square meters, including office area 15 square meters.

2. 1 Medical professionals are responsible persons of the enterprise.

3, product management directory

Note: If the above three points are met, the filing of Class II medical devices can basically be handled.

Category III: The State Administration of Medical Products handles medical device licenses.

Three types of medical devices refer to medical devices implanted in human body to support and maintain life, which are potentially dangerous to human body, and their safety and effectiveness must be strictly controlled. Therefore, the state's control over this piece is very strict. Therefore, for Class I and Class II, because of the low risk, only an ordinary company is needed, and Class II has moderate risk, and it is also necessary to make a record.

The third kind of medical devices are those with high risk and need to be strictly controlled and managed by special measures to ensure their safety and effectiveness, such as common infusion sets, syringes, intravenous indwelling needles, heart stents, ventilators, CT, magnetic resonance imaging and so on. Its products and production and business activities are managed by the State Administration, provincial food and drug supervision departments and municipal food and drug supervision departments with districts, and medical device registration certificates and medical devices are issued respectively.

Licensing requirements for three types of medical devices:

1. Address requirements: generally, the office area shall not be less than 100 square meter, and the warehouse area shall not be less than 60 square meters;

2. Disposable sterility: the office area is not less than 60 square meters, and the warehouse area is not less than 80 square meters;

3. In vitro diagnostic reagents: the office area is not less than 60 square meters, the warehouse area is not less than 100 square meters, and the refrigerating room area is not less than 40 cubic meters.

4. Personnel requirements: 3 people with bachelor degree in related medical industry.

Matters needing attention in handling three types of medical device licenses:

1. The office address is commercial, and the area is subject to the building area on the property ownership certificate;

2, in vitro diagnostic reagents must have a cold room, and 40 cubic meters, medical freezer useless, must be a cold room; Because it involves the follow-up teacher's on-site investigation;

3. The third-class personnel must be in the undergraduate medical industry, and then apply for the third-class medical device license. The teacher there has an interview, so this person is very important and cannot be affiliated. The annual inspection also involves these three types of people, so the most important thing to apply for the third-class medical device license is the personnel. Our Xunling enterprise service has no address, but the staff can't provide it.

4. The registered address in the company's business license should be consistent with the actual office address. If the address on the business license is the park address, it needs to be moved to the actual office address or the address provided by us, because not every park address can increase the business scope of the related three types of medical devices, and without this business scope, it is impossible to apply for the three types of medical device licenses;

5 sales of three types of medical devices must have a registration certificate. With this certificate, we can be sure that the three types of medical devices are qualified and formal. Then, apply for three types of medical device licenses and submit materials. This product registration certificate is one of the most important materials.

What is a CT machine?

CT is "computed tomography" or "computed tomography". The abbreviation of CT is the biggest breakthrough of X-ray diagnosis since Roentgen discovered X-ray in 1895, which is the product of the combination of computer control technology and X-ray inspection photography technology. CT was successfully developed by British physicist hounsfield in 197 1 year. It was first used for the diagnosis of brain diseases, and then extended to general examination in 1976. This is a great revolution of X-ray in radiology.

China also introduced this new technology in the late 1970s. In a short period of 30 years, thousands of various types of CT machines have been installed in hospitals all over the country and even in counties and townships, and CT examination has quickly spread all over the country, becoming an indispensable equipment for medical diagnosis.

Medical device business record inquiry entrance?

Search on the website of the State Administration of Medical Supplies and open the column of "Medical Devices": (/ylqx/index.html).

Click the link to enter the website, and you will see a medical device inquiry entrance on the right side of the page. Don't hurry to order which one to enter. You should first determine whether the medical device you are asking about is imported or made in China. If it is domestic, click "domestic equipment", if it is imported, click "imported equipment". You can view the filing information.