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.
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;
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.
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How to treat the date of making the band-aid record number?
Read the instructions. If the package has a shelf life of 3 or 5 years, look at the batch number. If it exceeds 2008062 1, it can be judged as the shelf life. If it is before 2008062 1, it can be judged as the production date.
Can Class II medical device licenses produce health care products?
Medical device license, unable to produce health care products, according to the corresponding management regulations and policies, as well as the corresponding operating procedures and manuals. The Medical Device License is a license that cannot be used as a health care product.
What documents do you need for a band-aid?
Class II devices requiring business license, medical device license or filing.
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.