The medical device registration license number refers to the license number of the Medical Device Business License. To apply for the registration of medical device business license, it is necessary to provide the relevant certification materials required for filing to the registration authority, and only after the approval of the registration authority can the medical device business license be processed. The business license number of medical devices is the registration license number of medical devices. Therefore, the number of medical device registration licenses refers to the number of medical device business licenses.
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.
Do I need a business license for the first-class filing certificate?
Class I medical devices do not need a business license.
According to Article 4 of Chapter 1 of the Measures for the Supervision and Administration of Medical Devices:
According to the risk degree of medical devices, medical devices are classified and managed. There is no need for licensing and filing for operating Class I medical devices, filing management for operating Class II medical devices and licensing management for operating Class III medical devices.
In order to strengthen the supervision and management of medical device operation, standardize the operation behavior of medical devices, and ensure the safety and effectiveness of medical devices, the Measures for the Supervision and Management of Medical Device Operation are formulated according to the Regulations on the Supervision and Management of Medical Devices. Issued by China Food and Drug Administration on July 30th, 20 14, and effective as of October 30th, 20 14.
How to enter the medical device production and operation license filing information system?
Which province and city are you from? First, go to the local food and drug administration in official website; Then, find the service guide module, which has a detailed medical device production and operation license filing information system; Note that the requirements of each provincial and municipal food and drug administration will be different.
Specific landing: the necessity of medical device production registration?
As a tool to prevent, diagnose and treat diseases, medical devices are commodities that need special management. In order to enable the public to obtain safe and effective medical devices, China implements an access system for the sale of medical devices. The applicant/registrant shall apply to the relevant supervision and administration departments of China for filing or registration, and shall not be listed until it is approved.
For medical device R&D and manufacturing enterprises, it is the only way for products to be legally listed to understand the requirements and processes of registration application and prepare application materials according to relevant requirements.