What is the management of Class I medical devices?
The first class of medical devices to implement the record management. You can apply for filing to the municipal market supervision department of the district.
What is the role of the first class medical device record voucher?
1, the first class of medical devices for the record vouchers include: "the first class of medical devices for the record vouchers" and "the first class of medical devices production for the record vouchers".
2, "Class I medical device record voucher" is the product of the approval of the certificate, equivalent to the product ID card, with this voucher, the product also has a legitimate registration qualification. 3, "Class I medical device production record voucher" is the product is allowed to produce the approval of the certificate, equivalent to the production license of the enterprise, if there is no such a voucher, the enterprise can not produce the product. 4, should be First do the "Class I medical device record voucher", get the voucher to do the "Class I medical device production record voucher". Otherwise, the information of "Class I Medical Device Production Record Voucher" will not be recorded. This is with the past first to the province to do the first class production registration, and then to the municipal bureau for the first class of the order of registration is just the opposite.What about the Class I medical device business license?
1, the first class of medical devices do not need to apply for a business license, is currently the implementation of the filing system, to the production enterprises to the municipal people's government of the location of the municipal people's food and drug supervision and management department for the record.
The first class medical device refers to, through routine management is sufficient to ensure its safety, effectiveness of medical devices. According to Article 5 of the Regulations for the Supervision and Administration of Medical Devices issued by the state, the state will implement classified management of medical devices.
Class I, Class II, Class III device filing and licensing instructions?
Class I: do not have to apply for a medical device license
Class I medical devices is a low-risk, the implementation of routine management can ensure its safety and effectiveness of medical devices, such as scalpels, surgical scissors, manual beds, medical ice packs, cooling patches, etc., its products and production activities by the location of the municipal food and drug regulatory departments 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" 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.
The first class device record query?
The first class medical device product filing information publicity
2021 (01)
According to the "Supervision and Administration of Medical Devices Regulations", "Measures for the Administration of Registration of Medical Devices" (the former State Food and Drug Administration Decree No. 4) and the former State Food and Drug Administration, "on the filing of Class I medical devices on the matters of public notice" (Announcement No. 26) provisions and procedures. (Announcement No.) of the provisions and procedures, the Board of Yunnan Hai Feng Pharmaceutical Co., Ltd. class I medical device product record materials for formal review, meet the relevant filing requirements, to be filed, the record information is hereby made public.