How to apply for medical device filing certificate?
1.
Online application. Applicants should be submitted through the online pre-approval of the application, the enterprise in the submission of paper application materials must be submitted at the same time the pre-acceptance number;
2.
Window acceptance. Enterprises to submit paper applications to the window, receiving and accepting personnel to verify the application materials, on the spot to make acceptance decisions;
3.
On the spot review. Accepted, the reviewer to review the material, make a decision on the spot review;
4.
Collect the results. Applicants in the window on the spot to receive the "production of Class I medical devices for the record voucher" or "do not pass the decision".
ctWhat formalities are required for an EIA?
One, the project
1. Preparation of the project book
2. Carry the project book to the district Economic Development Bureau to apply for the project file (ask before you go for the materials you need to provide for the file)
Two, the EIA
1. Record is completed, take the information on the case to the local Environmental Protection Bureau for environmental assessment, such as the EIA report form is required, the enterprise can fill out the report independently, and then the company can fill out the form on its own. If you only need the EIA report form, the enterprise can fill in independently, basically no cost; if you need to make the EIA report, the EPA will recommend several qualified assessment organizations to help complete the preparation of the report and the EIA in the work of the selection of the EIA organization that will incur costs.
2. Select an EIA organization to sign a contract, the cost generally depends on the amount of investment.
3. The EIA organization came to view the site, the enterprise to provide all the information required in the EIA and all the details (production process, the use of a variety of raw materials and the annual amount of details, storage methods, waste disposal methods, raw material composition, etc.). In addition, there is no noise, how to solve; there is no industrial wastewater, how to deal with; there is no exhaust gas, how to deal with; there is no waste residue, how to deal with; how to deal with a variety of industrial waste, etc.;).
One class two class three device filing and licensing instructions?
Class I: do not have to apply for a medical device license
Class I medical devices are low-risk, the implementation of routine management can ensure their safety and effectiveness of medical devices, such as scalpels, surgical scissors, manual beds, medical ice packs, cooling paste, etc., its products and production activities by the location of the municipal food and drug regulatory authorities to implement the filing of management. Business activities are all liberalized, neither permit nor record, only need to obtain a business license issued by the business sector.
Class II: Municipal Food and Drug Administration for medical equipment business preparedness
Class II medical devices is a medium risk, need to strictly control the management to ensure its safety and effectiveness of medical devices, such as band-aids, condoms, thermometers, blood pressure monitors, oxygen concentrators, nebulizers, etc., common in our daily lives, its products and production activities by the provincial food and drug regulatory departments to implement licensing management, respectively, issued the "Medical Device Registration Certificate", "Medical Device Registration Certificate", "Medical Device Registration Certificate", "Medical Device Registration Certificate", "Medical Device Registration Certificate" and "Medical Device Registration Certificate". Issued respectively to the "Medical Device Registration Certificate" and "Medical Device Manufacturing License". Business activities by the municipal food and drug regulatory authorities to implement record management.
Requirements for Class II Medical Devices
1, 45 square feet of storage, including 15 square feet of office space
2, a medical professional as the person in charge of the enterprise
3, the product business directory
Note: In line with the above 3 points, basically can be processed for the record of the second class of medical devices.
Class III: State Drug Administration for medical device license
Class III medical device refers to the implantation of the human body, used to support, maintain life, potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices. Therefore, the state control in this area is very strict, then for a class, class II, a class due to the low degree of risk, only need to apply for an ordinary company on the line, class II has a medium risk, so it is also necessary to do a filing.
The third class of medical devices is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices, such as common infusion sets, syringes, intravenous needles, cardiac stents, respiratory machines, CT, nuclear magnetic **** vibration, etc., its products and production and operation activities, respectively, by the State General Administration of the food and drug regulatory departments at the provincial level and the municipal food and drug regulatory department of the district The implementation of licensing management, respectively, issued by the "Medical Device Registration Certificate", "Medical Device Manufacturing License", "Medical Device Business License".
For three types of medical device license requirements:
1. Address requirements: general class: office area of not less than 100 square feet, warehouse area of not less than 60 square feet;
2. Disposable sterile: office area of not less than 60 square feet, warehouse area of not less than 80;
3. In vitro diagnostic reagents: office area of not less than 60 square feet, warehouse area of Not less than 100 square feet, cold room area of not less than 40 cubic
4. Personnel requirements: three bachelor's degree related medical industry.
For three types of medical equipment license notes:
1, office address needs to be commercial nature, the area of the building area on the real estate license shall prevail;
2, in vitro diagnostic reagents must have a cold room, and 40 cubic meters, medical freezers are useless, it must be a cold room; as it relates to the follow-up teacher to the site survey;
3, three personnel Must be undergraduate medical industry, follow-up for the three types of medical device license, the teacher over there to interview, so this personnel is very important, can not rely on, the annual inspection also involves these three personnel, so the most important for the three types of medical device license is the personnel, the address does not have our XunLing enterprise services can provide, but the personnel can not provide.
4, the company's business license on the registered address needs to be consistent with the actual office address, such as the business license address is the park address, then you need to migrate to the actual office address, or the address we provide, because not every park address can increase the scope of business related to the three types of medical devices, without the scope of this business will not be able to apply for a license for the three types of medical devices;
5, There must be its sales of three types of medical equipment product registration certificate, there is this certificate, in order to determine the three types of medical equipment is qualified regular, subsequent application for three types of medical equipment license,, submit materials, this product registration certificate is one of the most important materials.
What is a CT machine?
CT is "computerized X-ray tomography" or "computerized X-ray tomography" in English (ComputedTomography;) the abbreviation of CT, is the biggest breakthrough in X-ray diagnostics since the discovery of X-ray by Roentgen in 1895.
The biggest breakthrough in diagnostics is the product of the combination of the rapidly developing electronic computer control technology and X-ray inspection and photography technology in modern times. CT was successfully developed by the British physicist hounsfield in 1971, and was first used for the diagnosis of craniocerebral diseases, and then expanded to the whole body examination in 1976, which is a big revolution of X-ray in radiology.
China also introduced this new technology in the late 1970s, in just 30 years, all over the country and even county and township hospitals **** installed thousands of various types of CT machines, CT examination in the country rapidly layer open, become indispensable equipment for medical diagnosis.
Medical equipment business record inquiry entrance?
In the State Drug Administration website query, open the "medical equipment" section: (/ylqx/index.html)
Tap the link to enter the site, you will see the right side of the page there is a medical equipment query portal. Don't be in a hurry to click on which to enter, you should first determine their own query of medical equipment products are imported or domestic, if domestic on the point of "domestic devices", if imported, click on the "imported devices". You can query the record information.