Class I, Class II, Class III device filing and licensing instructions?
One class: no medical device license
The first class of medical devices is a low-risk, the implementation of routine management can ensure the safety and effectiveness of medical devices, such as scalpels, surgical scissors, manual beds, medical ice packs, cooling patches, and so on, the products and production activities by the location of the municipal food and drug regulatory authorities to implement the management of the record. 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.
Online filing process for Class II medical sales?
The second class of medical devices online filing process:
Application for the second class of medical devices business record should be submitted to the information:
1, business license;
2, legal representative, the person in charge of the enterprise, the person in charge of quality of the identity of the person in charge of the certificate, certificate of qualifications or titles;
3, organizational structure and departmental setup instructions;
4, business scope, business mode description;
5, business premises, warehouse address of the geographic location map, floor plan, documents proving property rights of housing or lease agreement; (with documents proving property rights of housing)
6, business facilities, equipment directory;
7, business quality management system, work procedures and other documents directory;
8, to encourage the Use of computer information management system;
9, proof of authorization of the operator;
10, signed and stamped scanned application form;
11, other supporting materials.
How to fill in the conditions of the second type of filing business depot?
1, the business premises item to fill in the content of: with the business license in the residence of the item content is consistent.
2, business premises conditions: (1) fill in the nature of the premises: rental or self-use.
(2) fill in the facilities and equipment: telephone, computer, display cabinets, storage cabinets, shelves, desks and chairs and other business products related to the necessary equipment.
What information is required for the record of Class II medical device business?
The required information is as follows:
Applying for the "Class II Medical Device Business Record Certificate" and want to successfully pass the Drug Inspection Bureau of the audit, which is the key to the three parts: the registered address, personnel requirements, related materials.
The second class of medical equipment business record on the registered address requirements:
1, office area of not less than 50 square meters;
2, warehouse area of not less than 50 square meters; (including in vitro diagnostic reagents need to be refrigerated warehouses)
3, including disposable consumables, if the requirements of the office address and the warehouse together with the area of not less than 150 square meters
Note: business premises and warehouses shall not be set up in residential housing
The second class of medical equipment business record personnel requirements:
1, the legal person and the person in charge of the enterprise needs to have a college degree or above, the professional does not require;
2, the person in charge of the quality of the need to have more than 3 years of experience, college education, graduated from the relevant professional;
Medical device related professional refers to: medical devices, biomedical engineering, machinery, electronics, medicine, bioengineering, chemistry, nursing, rehabilitation, testing, management, computers and other professions
The second class of medical devices business filing material requirements:
1, the second class of medical devices business filing application form
2, a copy of the business license and organization code certificate;
3, the legal representative, the person in charge of the enterprise, the quality of the person in charge of the identity, education or title certificate copy;
4, organization and departmental setup description;
5, the scope of business, the business mode of description
6, the business premises, warehouse address of the geographic location of the map, floor plan, documents proving ownership of the house or lease agreement (with) copy of House ownership documents) copies;
7, business facilities, equipment directory;
8, business quality management system, working procedures and other documents directory;
9, proof of authorization of the operator;
10, the basic information and functional description of the computer information management system (encouraging the second class of medical devices business enterprises to establish a computer information management system in line with the requirements of the quality management of medical equipment) Business quality management requirements of the computer information management system, such as this, can be exempted from the description);
11, other supporting materials (such as the operation of in vitro diagnostic reagents, in vitro diagnostic reagents according to the standard requirements of the application for the operation of the medical examiner and cold-chain facilities and equipment, and other additional materials).
Two types of filing business description?
Medical devices for the record the local food and drug supervision department will have the relevant provisions and format, specific consultation with the local. The following is for reference only.
The scope of business: in accordance with the provisions of the Medical Device Classification Catalog management category, class code name to determine. For example: "Class II Medical Devices: 6846 Hearing Aids".
Method of operation: wholesale, retail, wholesale and retail